Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT04639258
Status:
TERMINATED
Last Update Posted:
2024-01-10
First Post:
2020-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.waltonen@medtronic.com', 'phone': '763-526-0424', 'title': 'Robert Waltonen', 'organization': 'Medtronic Structural Heart & Aortic'}, 'certainAgreement': {'otherDetails': "Within 60 days of receipt Medtronic (MDT) will verify presence of Confidential Information (CI) \\& won't censor or interfere with presentation/conclusions except to protect CI (other than Study Data) \\& its rights in patentable or copyrightable materials, \\& check technical accuracy of MDT data. If told by MDT that Publication contains CI or technical errors of MDT data, PI will make requested changes before publishing/presenting. PI will delay publication up to 90 more days, if requested.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination of the study prior to any attempted TAVR procedures led to no evaluable subjects for data analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from study enrollment (consent) through study exit, up to 151 days. First subject was enrolled on 28 May 2021 and last subject was exited on 28 Feb 2022. No study subjects were treated. If subjects had been treated all AEs would have been reported through 6 months post-procedure. After 6 months post-procedures only serious adverse events, device-related events, and device deficiencies would have been reported.', 'description': "The definitions used for AEs and SAEs is too long for the field. The definitions differed in that the CIP used the definitions found in ISO14100:2020.\n\nInvestigators are required to evaluate and document in the subject's medical records all adverse events and device deficiencies observed in study subjects from the time they are enrolled until they are exited from the study. All AEs should be followed through their resolution.", 'eventGroups': [{'id': 'EG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS with an attempted TAVR procedure', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Scalp laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parasthesia, left thumb and index finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bilateral ovarian cysts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Saccular infrarenal abdominal aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Coronary stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left radial artery pseudoaneurysm following study specific angiogram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematome, left radial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'All-cause and Cardiovascular Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of all-cause and cardiovascular mortality', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'All-cause and Cardiovascular Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of all-cause and cardiovascular mortality', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'All Stroke (Disabling and Non-disabling)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of disabling and non-disabling stroke', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'All Stroke (Disabling and Non-disabling)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of disabling and non-disabling stroke', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Myocardial Infarction (Periprocedural and Spontaneous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of periprocedural and spontaneous myocardial infarction', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Myocardial Infarction (Periprocedural and Spontaneous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of periprocedural and spontaneous myocardial infarction', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Acute Kidney Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of acute kidney injury', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Acute Kidney Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of acute kidney injury', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Major Vascular Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of major vascular complications', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Major Vascular Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of major vascular complications', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Life-threatening Bleed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of life-threatening (or disabling) bleed', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Life-threatening Bleed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of life-threatening (or disabling) bleed', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'New Permanent Pacemaker Implantation (PPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'New Permanent Pacemaker Implantation (PPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'New Intraventricular Conduction Delays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'New Intraventricular Conduction Delays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'New-onset Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'New-onset Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Valve-related Dysfunction Requiring Repeat Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of valve-related dysfunction requiring repeat procedure', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Valve-related Dysfunction Requiring Repeat Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of valve-related dysfunction requiring repeat procedure', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Device Success (VARC-2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Discharge (12 hours to 7 days post-procedure)', 'description': 'The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity \\<3 m/sec), and absence of moderate or severe prosthetic valve regurgitation', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Cardiovascular and Heart Failure Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of cardiovascular and heart failure hospitalizations', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Cardiovascular and Heart Failure Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of cardiovascular and heart failure hospitalizations', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Heart Failure Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Rate of heart failure events', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Heart Failure Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Rate of heart failure events', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Discharge (12 hours to 7 days post-procedure)', 'description': 'Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Discharge (12 hours to 7 days post-procedure)', 'description': 'Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Discharge (12 hours to 7 days post-procedure)', 'description': 'Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Discharge (12 hours to 7 days post-procedure)', 'description': 'Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days', 'description': 'Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in New York Heart Association (NYHA) Functional Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days and 6 months', 'description': 'Reporting of NYHA classification change from baseline to 30 days and 6 months\n\nNYHA Classification criteria:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity.\n\nClass I: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Six-minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Reporting change from baseline in distance walked during 6MWT', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days and 6 months', 'description': 'KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Global Longitudinal Strain (GLS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Reporting of change in GLS from baseline by echocardiography', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': "Change From Baseline in Left Ventricular Filling Pressure (E:e')", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': "Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography", 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Stroke Volume Index (SVI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Reporting of change in stroke volume index (SVI) from baseline by echocardiography', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '6 months', 'description': 'Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'All-cause and Cardiovascular Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Annually through 5 years', 'description': 'Rate of all-cause and cardiovascular mortality', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'All Stroke (Disabling and Non-disabling)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Annually through 5 years', 'description': 'Rate of disabling and non-disabling strokes', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cardiovascular and Heart Failure Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Annually through 5 years', 'description': 'Rate of cardiovascular and heart failure hospitalizations', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Heart Failure Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Annually through 5 years', 'description': 'Rate of heart failure events', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'New York Heart Association (NYHA) Functional Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days, 6 months, and annually through 5 years', 'description': 'Reporting NYHA functional classification by timepoint following attempted procedure', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in New York Heart Association (NYHA) Functional Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Annually through 5 years', 'description': 'Reporting of NYHA classification change from baseline to 30 days and 6 months\n\nNYHA Classification criteria:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity.\n\nClass I: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Annually through 5 years', 'description': 'KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects with an attempted TAVR procedure.\n\nNo data is reported as statistical analysis plan specifies that results would be reported for:\n\n* Attempted Implant (all subjects with an attempted procedure)\n* Implanted (all subjects with an attempted procedure where the study device is implanted)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Annually through 5 years', 'description': 'Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Annually through 5 years', 'description': 'Reporting of prosthetic valve hemodynamic performance by effective orifice area (EOA)', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Annually through 5 years', 'description': 'Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular prosthetic regurgitation by Doppler echocardiography', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Annually through 5 years', 'description': 'Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Prosthetic Valve Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days, 6 months, and annually through 5 years', 'description': 'Rate of prosthetic valve thrombosis', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Prosthetic Valve Endocarditis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days, 6 months, and annually through 5 years', 'description': 'Rate of prosthetic valve endocarditis', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bioprosthetic Valve Dysfunction (BVD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days, 6 months, and annually through 5 years', 'description': 'Rate of bioprosthetic valve dysfunction (BVD)', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bioprosthetic Valve Failure (BVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': '30 days, 6 months, and annually through 5 years', 'description': 'Rate of bioprosthetic valve failure (BVF)', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Valve-related Dysfunction Requiring Repeat Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'timeFrame': 'Annually through 5 years', 'description': 'Rate of valve-related dysfunction requiring repeat procedure', 'reportingStatus': 'POSTED', 'populationDescription': 'Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Early study termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TAVR', 'description': 'Up to 75 subjects with moderate, symptomatic AS with an attempted TAVR procedure'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'BG000', 'lowerLimit': '68', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'NYHA Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Class I', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Class II', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Class III', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Class IV', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown/Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'New York Heart Association (NYHA) Classification:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity.\n\nClass I: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'unitOfMeasure': 'Participants'}, {'title': 'Society of Thoracic Surgeons (STS) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'BG000', 'lowerLimit': '0.8', 'upperLimit': '5.9'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: Society of Thoracic Surgeons (STS) score of predicted risk of 30-day mortality following surgical aortic valve replacement. The score is measured as a percentage (0-100%) with higher scores representing a higher probability of mortality at 30 days.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'STS score was reported for 6 participants'}, {'title': 'BSA', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'BG000', 'lowerLimit': '1.4', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEAN', 'description': 'Body surface area reporting in meters squared', 'unitOfMeasure': 'm^2', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Body surface area was reported for 6 participants.'}], 'populationDescription': 'No subject had an attempted TAVR procedure.\n\nAs full baseline data is only required for subjects who are approved for treatment it was not reported for all subjects. No subjects were approved for treatment. Of the 11 enrolled (consented) subjects 8 had baseline data reported.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-09', 'size': 14349868, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-17T17:13', 'hasProtocol': True}, {'date': '2021-05-11', 'size': 398957, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-12T18:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Reevaluation of clinical strategy in this patient population led to a business decision to discontinue the study. Discontinuation is not due to any patient safety, patient welfare, or quality issues.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2020-11-05', 'resultsFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-09', 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'All-cause and Cardiovascular Mortality', 'timeFrame': 'Annually through 5 years', 'description': 'Rate of all-cause and cardiovascular mortality'}, {'measure': 'All Stroke (Disabling and Non-disabling)', 'timeFrame': 'Annually through 5 years', 'description': 'Rate of disabling and non-disabling strokes'}, {'measure': 'Cardiovascular and Heart Failure Hospitalizations', 'timeFrame': 'Annually through 5 years', 'description': 'Rate of cardiovascular and heart failure hospitalizations'}, {'measure': 'Heart Failure Events', 'timeFrame': 'Annually through 5 years', 'description': 'Rate of heart failure events'}, {'measure': 'New York Heart Association (NYHA) Functional Classification', 'timeFrame': '30 days, 6 months, and annually through 5 years', 'description': 'Reporting NYHA functional classification by timepoint following attempted procedure'}, {'measure': 'Change From Baseline in New York Heart Association (NYHA) Functional Classification', 'timeFrame': 'Annually through 5 years', 'description': 'Reporting of NYHA classification change from baseline to 30 days and 6 months\n\nNYHA Classification criteria:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity.\n\nClass I: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.'}, {'measure': 'Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': 'Annually through 5 years', 'description': 'KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography', 'timeFrame': 'Annually through 5 years', 'description': 'Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient'}, {'measure': 'Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography', 'timeFrame': 'Annually through 5 years', 'description': 'Reporting of prosthetic valve hemodynamic performance by effective orifice area (EOA)'}, {'measure': 'Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography', 'timeFrame': 'Annually through 5 years', 'description': 'Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular prosthetic regurgitation by Doppler echocardiography'}, {'measure': 'Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography', 'timeFrame': 'Annually through 5 years', 'description': 'Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography'}, {'measure': 'Prosthetic Valve Thrombosis', 'timeFrame': '30 days, 6 months, and annually through 5 years', 'description': 'Rate of prosthetic valve thrombosis'}, {'measure': 'Prosthetic Valve Endocarditis', 'timeFrame': '30 days, 6 months, and annually through 5 years', 'description': 'Rate of prosthetic valve endocarditis'}, {'measure': 'Bioprosthetic Valve Dysfunction (BVD)', 'timeFrame': '30 days, 6 months, and annually through 5 years', 'description': 'Rate of bioprosthetic valve dysfunction (BVD)'}, {'measure': 'Bioprosthetic Valve Failure (BVF)', 'timeFrame': '30 days, 6 months, and annually through 5 years', 'description': 'Rate of bioprosthetic valve failure (BVF)'}, {'measure': 'Valve-related Dysfunction Requiring Repeat Procedure', 'timeFrame': 'Annually through 5 years', 'description': 'Rate of valve-related dysfunction requiring repeat procedure'}], 'primaryOutcomes': [{'measure': 'All-cause and Cardiovascular Mortality', 'timeFrame': '30 days', 'description': 'Rate of all-cause and cardiovascular mortality'}, {'measure': 'All-cause and Cardiovascular Mortality', 'timeFrame': '6 months', 'description': 'Rate of all-cause and cardiovascular mortality'}, {'measure': 'All Stroke (Disabling and Non-disabling)', 'timeFrame': '30 days', 'description': 'Rate of disabling and non-disabling stroke'}, {'measure': 'All Stroke (Disabling and Non-disabling)', 'timeFrame': '6 months', 'description': 'Rate of disabling and non-disabling stroke'}, {'measure': 'Myocardial Infarction (Periprocedural and Spontaneous)', 'timeFrame': '30 days', 'description': 'Rate of periprocedural and spontaneous myocardial infarction'}, {'measure': 'Myocardial Infarction (Periprocedural and Spontaneous)', 'timeFrame': '6 months', 'description': 'Rate of periprocedural and spontaneous myocardial infarction'}, {'measure': 'Acute Kidney Injury', 'timeFrame': '30 days', 'description': 'Rate of acute kidney injury'}, {'measure': 'Acute Kidney Injury', 'timeFrame': '6 months', 'description': 'Rate of acute kidney injury'}, {'measure': 'Major Vascular Complications', 'timeFrame': '30 days', 'description': 'Rate of major vascular complications'}, {'measure': 'Major Vascular Complications', 'timeFrame': '6 months', 'description': 'Rate of major vascular complications'}, {'measure': 'Life-threatening Bleed', 'timeFrame': '30 days', 'description': 'Rate of life-threatening (or disabling) bleed'}, {'measure': 'Life-threatening Bleed', 'timeFrame': '6 months', 'description': 'Rate of life-threatening (or disabling) bleed'}, {'measure': 'New Permanent Pacemaker Implantation (PPI)', 'timeFrame': '30 days', 'description': 'Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)'}, {'measure': 'New Permanent Pacemaker Implantation (PPI)', 'timeFrame': '6 months', 'description': 'Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)'}, {'measure': 'New Intraventricular Conduction Delays', 'timeFrame': '30 days', 'description': 'Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)'}, {'measure': 'New Intraventricular Conduction Delays', 'timeFrame': '6 months', 'description': 'Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)'}, {'measure': 'New-onset Atrial Fibrillation', 'timeFrame': '30 days', 'description': 'Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)'}, {'measure': 'New-onset Atrial Fibrillation', 'timeFrame': '6 months', 'description': 'Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)'}, {'measure': 'Valve-related Dysfunction Requiring Repeat Procedure', 'timeFrame': '30 days', 'description': 'Rate of valve-related dysfunction requiring repeat procedure'}, {'measure': 'Valve-related Dysfunction Requiring Repeat Procedure', 'timeFrame': '6 months', 'description': 'Rate of valve-related dysfunction requiring repeat procedure'}, {'measure': 'Device Success (VARC-2)', 'timeFrame': 'Discharge (12 hours to 7 days post-procedure)', 'description': 'The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity \\<3 m/sec), and absence of moderate or severe prosthetic valve regurgitation'}, {'measure': 'Cardiovascular and Heart Failure Hospitalizations', 'timeFrame': '30 days', 'description': 'Rate of cardiovascular and heart failure hospitalizations'}, {'measure': 'Cardiovascular and Heart Failure Hospitalizations', 'timeFrame': '6 months', 'description': 'Rate of cardiovascular and heart failure hospitalizations'}, {'measure': 'Heart Failure Events', 'timeFrame': '30 days', 'description': 'Rate of heart failure events'}, {'measure': 'Heart Failure Events', 'timeFrame': '6 months', 'description': 'Rate of heart failure events'}, {'measure': 'Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography', 'timeFrame': 'Discharge (12 hours to 7 days post-procedure)', 'description': 'Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient'}, {'measure': 'Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography', 'timeFrame': '30 days', 'description': 'Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient'}, {'measure': 'Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography', 'timeFrame': '6 months', 'description': 'Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient'}, {'measure': 'Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography', 'timeFrame': 'Discharge (12 hours to 7 days post-procedure)', 'description': 'Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.'}, {'measure': 'Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography', 'timeFrame': '30 days', 'description': 'Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.'}, {'measure': 'Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography', 'timeFrame': '6 months', 'description': 'Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.'}, {'measure': 'Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography', 'timeFrame': 'Discharge (12 hours to 7 days post-procedure)', 'description': 'Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography'}, {'measure': 'Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography', 'timeFrame': '30 days', 'description': 'Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography'}, {'measure': 'Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography', 'timeFrame': '6 months', 'description': 'Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography'}, {'measure': 'Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography', 'timeFrame': 'Discharge (12 hours to 7 days post-procedure)', 'description': 'Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography'}, {'measure': 'Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography', 'timeFrame': '30 days', 'description': 'Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography'}, {'measure': 'Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography', 'timeFrame': '6 months', 'description': 'Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography'}, {'measure': 'Change From Baseline in New York Heart Association (NYHA) Functional Classification', 'timeFrame': '30 days and 6 months', 'description': 'Reporting of NYHA classification change from baseline to 30 days and 6 months\n\nNYHA Classification criteria:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity.\n\nClass I: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.'}, {'measure': 'Change From Baseline in Six-minute Walk Test (6MWT)', 'timeFrame': '6 months', 'description': 'Reporting change from baseline in distance walked during 6MWT'}, {'measure': 'Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': '30 days and 6 months', 'description': 'KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Change From Baseline in Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '6 months', 'description': 'Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography'}, {'measure': 'Change From Baseline in Global Longitudinal Strain (GLS)', 'timeFrame': '6 months', 'description': 'Reporting of change in GLS from baseline by echocardiography'}, {'measure': "Change From Baseline in Left Ventricular Filling Pressure (E:e')", 'timeFrame': '6 months', 'description': "Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography"}, {'measure': 'Change From Baseline in Stroke Volume Index (SVI)', 'timeFrame': '6 months', 'description': 'Reporting of change in stroke volume index (SVI) from baseline by echocardiography'}, {'measure': 'Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP)', 'timeFrame': '6 months', 'description': 'Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.', 'detailedDescription': 'Single-arm, descriptive, multi-center, international\n\nAll subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm\\^2, or aortic valve area index ≤ 0.6 cm\\^2/m\\^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec\n* Subject denies symptoms attributable to aortic stenosis, including but not limited to:\n\n * Dyspnea on rest or exertion\n * Angina\n * Syncope in the absence of another identifiable cause\n * Fatigue\n * Left Ventricular Ejection Fraction (LVEF) \\>50%\n\nKey Exclusion Criteria:\n\n* Age \\<65 years\n* Class I indication for cardiac surgery\n* Bicuspid, unicuspid, or quadricuspid aortic valve\n* In need of and suitable for coronary revascularization'}, 'identificationModule': {'nctId': 'NCT04639258', 'briefTitle': 'Medtronic Evolut™ EXPAND TAVR I Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'Medtronic Evolut™ EXPAND TAVR I Feasibility Study', 'orgStudyIdInfo': {'id': 'D00266108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medtronic Evolut™ PRO+ System', 'description': 'All study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System.', 'interventionNames': ['Device: Medtronic Evolut™ PRO+ System']}], 'interventions': [{'name': 'Medtronic Evolut™ PRO+ System', 'type': 'DEVICE', 'description': 'TAVR treatment with Medtronic Evolut™ PRO+ System', 'armGroupLabels': ['Medtronic Evolut™ PRO+ System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91360', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Los Robles Hospital & Medical Center', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '11030-3816', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '17043', 'city': 'Wormleysburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Pinnacle Harrisburg Campus', 'geoPoint': {'lat': 40.26287, 'lon': -76.91386}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora Saint Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'country': 'Canada', 'facility': 'IUCPQ', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}], 'overallOfficials': [{'name': 'Paul Sorajja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allina Health System'}, {'name': 'Josep Rodes-Cabau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation IUCPQ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}