Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-02 @ 10:39 AM
Study NCT ID:
NCT03423459
Status:
UNKNOWN
Last Update Posted:
2023-05-26
First Post:
2018-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CoreValve Evolut Pro Prospective Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2018-01-18', 'studyFirstSubmitQcDate': '2018-01-30', 'lastUpdatePostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device success:', 'timeFrame': '30 days', 'description': 'Absence of procedural mortality Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient\\<20 mm Hg or peak velocity\\<3 m/s, AND no moderate or severe prosthetic valve regurgitation)'}, {'measure': 'All Cause Mortality', 'timeFrame': '30 days', 'description': 'all causes of death'}, {'measure': 'All Stroke (disabling and non-disabling', 'timeFrame': '30 days', 'description': 'Stroke will evaluated using the VARC-2 definition'}, {'measure': 'Life Threatening Bleeding', 'timeFrame': '30 Days', 'description': 'Life Threatening Bleeding will be evaluated using the VARC-2 definition'}, {'measure': 'Acute Kidney Injury Stage 2 or 3', 'timeFrame': '30 days', 'description': 'AKI will be evaluated using the VARC-2 definition of Stage 2 or 3 AKI'}, {'measure': 'Coronary Artery Obstruction requiring intervention', 'timeFrame': '30 days', 'description': 'This will be assessed if by noting whether the patient has a re intervention'}, {'measure': 'Major Vascular Complication', 'timeFrame': '30 days', 'description': 'Major Vascular Complication will be evaluated using the VARC-2 definition of Major Vascular Complication'}, {'measure': 'Valve - related Dysfunction', 'timeFrame': '30 Days', 'description': 'Valve related dysfunction will be evaluated by determining whether the subject has a repeat procedure such as a BAV, TAVI, or SAVR'}], 'secondaryOutcomes': [{'measure': 'Prosthetic valve dysfunction #1', 'timeFrame': '1 year', 'description': 'Mean aortic valve gradient ≥20 mm Hg'}, {'measure': 'Prosthetic valve dysfunction #2', 'timeFrame': '1 year', 'description': 'Moderate-severe transvalvular aortic regurgitation as determined by the echo core lab'}, {'measure': 'Prosthetic valve dysfunction #3', 'timeFrame': '1 year', 'description': 'Abnormal leaflet thickening on CT as determined by the CT Core lab'}, {'measure': 'Prosthetic valve dysfunction #4', 'timeFrame': '1 year', 'description': 'Decreased leaflet mobility on CT as determined by the CT Core lab'}, {'measure': 'Prosthetic valve dysfunction', 'timeFrame': '1 year', 'description': 'Leaflet thrombosis on CT as determined by the CT Core lab'}, {'measure': 'Reduction in PVL', 'timeFrame': 'Discharge thru to 1 year', 'description': 'This will be evaluated by echo core lab findings'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '38769727', 'type': 'DERIVED', 'citation': 'Merdler I, Case BC, Bhogal S, Reddy PK, Zhang C, Ali S, Gallino PE, Jackman C, Ben-Dor I, Satler LF, Cohen JE, Rogers T, Waksman R. Temporal trends with the Evolut family of self-expanding transcatheter heart valves: A single-center experience. Catheter Cardiovasc Interv. 2024 Jul;104(1):125-133. doi: 10.1002/ccd.31088. Epub 2024 May 20.'}, {'pmid': '35321859', 'type': 'DERIVED', 'citation': 'Medranda GA, Soria Jimenez CE, Torguson R, Case BC, Forrestal BJ, Ali SW, Shea C, Zhang C, Wang JC, Gordon P, Ehsan A, Wilson SR, Levitt R, Parikh P, Bilfinger T, Hanna N, Buchbinder M, Asch FM, Weissman G, Shults CC, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R, Rogers T. Lifetime management of patients with symptomatic severe aortic stenosis: a computed tomography simulation study. EuroIntervention. 2022 Aug 5;18(5):e407-e416. doi: 10.4244/EIJ-D-21-01091.'}, {'pmid': '33272031', 'type': 'DERIVED', 'citation': 'Forrestal BJ, Case BC, Yerasi C, Shea C, Torguson R, Zhang C, Ben-Dor I, Deksissa T, Ali S, Satler LF, Shults C, Weissman G, Wang JC, Khan JM, Waksman R, Rogers T. Risk of Coronary Obstruction and Feasibility of Coronary Access After Repeat Transcatheter Aortic Valve Replacement With the Self-Expanding Evolut Valve: A Computed Tomography Simulation Study. Circ Cardiovasc Interv. 2020 Dec;13(12):e009496. doi: 10.1161/CIRCINTERVENTIONS.120.009496. Epub 2020 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry.', 'detailedDescription': 'The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. This latest generation device features an outer wrap to improve annular sealing and reduce paravalvular leak.\n\nIn this observational study, baseline demographic and imaging characteristics, procedural details and clinical outcomes of patients undergoing transcatheter aortic valve replacement with the CoreValve Evolut PRO will be prospectively collected into a registry database. The institutional Heart Team will select patients according to standard practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is a prospective registry of subjects with symptomatic severe aortic stenosis undergoing TAVR with a commercially-approved self-expanding transcatheter heart valve. A subgroup of subjects will undergo additional research contrast-enhanced 4D CT at 30-60 days after TAVR. Otherwise, all additional test and TAVR implantation procedures are as per standard of care.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptomatic severe aortic stenosis\n2. Intermediate, high or extreme surgical risk\n3. The institutional Heart Team determines that transcatheter aortic valve replacement with an Evolut Pro device is appropriate\n\nExclusion Criteria:\n\n1. Subject unable or unwilling to give informed consent\n2. For subjects in the CT arm only, renal function precluding the administration of iodinated contrast for cardiac CT (eGFR \\< 30 ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media.\n3. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures'}, 'identificationModule': {'nctId': 'NCT03423459', 'briefTitle': 'CoreValve Evolut Pro Prospective Registry', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'CoreValve Evolut Pro Prospective Registry', 'orgStudyIdInfo': {'id': 'EPROMPT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CT Cohort', 'description': '1. Compare the rate of ≥mild PVL in patients with none/mild versus moderate/severe LVOT calcification.\n2. Comparison of the rate of PPM implantation in patients with none/mild versus moderate/severe LVOT calcification.\n3. Determine how the Evolut PRO conforms to LVOT calcification.\n4. Compare the impact of LVOT calcification on the implantation depth of the Evolut PRO.\n5. Analyze the interaction and geometry of the Evolut PRO in patients with moderate/severe LVOT calcification.\n6. Assess for leaflet thickening, subclinical leaflet thrombosis and/or restricted leaflet motion 30-60 days after TAVR.', 'interventionNames': ['Device: TAVR']}, {'label': 'Non-CT Cohort', 'description': '1. Compare the rate of ≥mild PVL with the Evolut PRO with a propensity score matched cohort of historical control subjects who underwent TAVR with the Evolut R and/or CoreValve within the MedStar Health System.\n2. Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict ≥mild PVL.\n3. Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict PPM implantation.', 'interventionNames': ['Device: TAVR']}], 'interventions': [{'name': 'TAVR', 'type': 'DEVICE', 'description': 'Transcatheter Aortic Valve Replacement', 'armGroupLabels': ['CT Cohort', 'Non-CT Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Medstar Union Memorial Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic Cardiovascular', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}