Viewing Study NCT01732835

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Ignite Creation Date: 2025-12-24 @ 10:32 PM

Ignite Modification Date: 2026-02-25 @ 11:47 PM

Study NCT ID: NCT01732835

Status: COMPLETED

Last Update Posted: 2017-03-10

First Post: 2012-11-20

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'John.wheeler@biostable-s-e.com', 'phone': '512-386-1996', 'title': 'John Wheeler', 'organization': 'Biostable Science and Engineering, Inc.'}, 'certainAgreement': {'otherDetails': 'Publication by the investigator was not allowed until completion of the trial. All proposed publications must be cleared by unanimous vote of a publication committee consisting of the sponsor and representatives of the study investigators. Publication materials must be submitted for review at least 60 day in advance of publication. The Sponsor may embargo publication for 60 additional days to allow for patent filing or may prevent publication if filling of such application would be premature.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through 2 years for the 49 participants receiving the implant', 'eventGroups': [{'id': 'EG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair', 'otherNumAtRisk': 49, 'otherNumAffected': 38, 'seriousNumAtRisk': 49, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'aortic insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abnormal LDH value', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperthyreosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased C-reactive protein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bleeding event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sternal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thoracic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'aortic insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiac decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'reflux esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'worsening of wound healing disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'loosening of wire cerclages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'presternal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lumbago', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bronchopulmonary infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pleuropneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pulmonary spasticity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '1+', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': '2+', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '3+', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '4+', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an echocardiogram evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Implant Procedure Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '86.0', 'upperLimit': '99.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'discharge or 14 days postprocedure, whichever comes first', 'description': 'Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.', 'unitOfMeasure': 'percentage of implant procedures', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Actuarial Freedom From Clinical Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000', 'lowerLimit': '80.9', 'upperLimit': '98.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aortic Insufficiency (AI) at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '1+', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': '2+', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': '3+', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '4+', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an echocardiogram evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'New York Heart Association (NYHA) Functional Capacity Classification at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an evaluation of this measure.'}, {'type': 'SECONDARY', 'title': 'New York Heart Association (NYHA) Functional Capacity Classification at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an evaluation of this measure.'}, {'type': 'SECONDARY', 'title': 'Peak Gradient - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '6.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Transthoracic echocardiography parameter', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.'}, {'type': 'SECONDARY', 'title': 'Peak Gradient - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '10.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 years', 'description': 'Transthoracic echocardiography parameter', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.'}, {'type': 'SECONDARY', 'title': 'Mean Gradient - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Transthoracic echocardiography parameter', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.'}, {'type': 'SECONDARY', 'title': 'Mean Gradient - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '5.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 years', 'description': 'Transthoracic echocardiography parameter', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.'}, {'type': 'SECONDARY', 'title': 'LV Mass - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.5', 'spread': '60.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Left ventricular mass. Transthoracic echocardiography parameter.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.'}, {'type': 'SECONDARY', 'title': 'LV Mass - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.4', 'spread': '60.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 years', 'description': 'Left ventricular mass. Transthoracic echocardiography parameter.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.'}, {'type': 'SECONDARY', 'title': 'LVID Diastole - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Left ventricular internal dimension. Transthoracic echocardiography parameter.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.'}, {'type': 'SECONDARY', 'title': 'LVID Diastole - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 years', 'description': 'Left ventricular internal dimension. Transthoracic echocardiography parameter.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.'}, {'type': 'SECONDARY', 'title': 'LVID Systole - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair\n\nHAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Left ventricular internal dimension. 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Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort'}, {'measure': 'New York Heart Association (NYHA) Functional Capacity Classification at 2 Years', 'timeFrame': '2 years', 'description': 'Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort'}, {'measure': 'Peak Gradient - Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Transthoracic echocardiography parameter'}, {'measure': 'Peak Gradient - Change From Baseline', 'timeFrame': 'Baseline and 2 years', 'description': 'Transthoracic echocardiography parameter'}, {'measure': 'Mean Gradient - Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Transthoracic echocardiography parameter'}, {'measure': 'Mean Gradient - Change From Baseline', 'timeFrame': 'Baseline and 2 years', 'description': 'Transthoracic echocardiography parameter'}, {'measure': 'LV Mass - Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Left ventricular mass. Transthoracic echocardiography parameter.'}, {'measure': 'LV Mass - Change From Baseline', 'timeFrame': 'Baseline and 2 years', 'description': 'Left ventricular mass. Transthoracic echocardiography parameter.'}, {'measure': 'LVID Diastole - Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Left ventricular internal dimension. Transthoracic echocardiography parameter.'}, {'measure': 'LVID Diastole - Change From Baseline', 'timeFrame': 'Baseline and 2 years', 'description': 'Left ventricular internal dimension. Transthoracic echocardiography parameter.'}, {'measure': 'LVID Systole - Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Left ventricular internal dimension. Transthoracic echocardiography parameter.'}, {'measure': 'LVID Systole - Change From Baseline', 'timeFrame': 'Baseline and 2 years', 'description': 'Left ventricular internal dimension. Transthoracic echocardiography parameter.'}, {'measure': 'LV Diastolic Volume - Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Left ventricular diastolic volume. Transthoracic echocardiography parameter.'}, {'measure': 'LV Diastolic Volume - Change From Baseline', 'timeFrame': 'Baseline and 2 years', 'description': 'Left ventricular diastolic volume. Transthoracic echocardiography parameter.'}, {'measure': 'LV Systolic Volume - Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Left ventricular systolic volume. Transthoracic echocardiography parameter.'}, {'measure': 'LV Systolic Volume - Change From Baseline', 'timeFrame': 'Baseline and 2 years', 'description': 'Left ventricular systolic volume. Transthoracic echocardiography parameter.'}, {'measure': 'LVEF - Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Left ventricular ejection fraction. Transthoracic echocardiography parameter.'}, {'measure': 'LVEF - Change From Baseline', 'timeFrame': 'Baseline and 2 years', 'description': 'Left ventricular ejection fraction. Transthoracic echocardiography parameter.'}, {'measure': 'Cardiac Output - Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Stroke volume x heart rate. Transthoracic echocardiography parameter.'}, {'measure': 'Cardiac Output - Change From Baseline', 'timeFrame': 'Baseline and 2 years', 'description': 'Stroke volume x heart rate. Transthoracic echocardiography parameter.'}, {'measure': 'Cardiac Index - Change From Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'Hemodynamic parameter computed as cardiac output divided by body surface area'}, {'measure': 'Cardiac Index - Change From Baseline', 'timeFrame': 'Baseline and 2 years', 'description': 'Hemodynamic parameter computed as cardiac output divided by body surface area'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aortic Insufficiency (AI) Aortic Regurgitation (AR)'], 'conditions': ['Aortic Insufficiency']}, 'descriptionModule': {'briefSummary': 'This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D intra-annular mounting frame.', 'detailedDescription': 'Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic valve to close completely during diastole which causes blood to flow from the aorta back into the left ventricle. Aortic Regurgitation (AR) is a frequent cause of both disability and death due to congestive heart failure, primarily in individuals forty or older, but can also occur in younger populations.\n\nTraditionally management of aortic regurgitation has been by aortic valve replacement, however, as has been observed in patients who have had mitral valve repair, the option of maintaining ones native aortic valve versus a replacement, either bioprosthetic or mechanical, can have added multiple benefits. The advantage of repair is the avoidance of prosthetic valve-related complications with bioprosthetic valves over 10-15 years or the need for anticoagulation with mechanical valves and the related problems of this therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is 18 years of age or older\n* Subject has tri-leaflet aortic valve morphology\n* Subject has documented aortic valve disease which may or may not include:\n\n 1. aortic valve insufficiency\n 2. aortic root pathology\n 3. pathology of the ascending aorta\n 4. patients with associated stable one or two vessel coronary disease requiring concomitant coronary bypass\n* Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve\n* Subject has reviewed and signed the written informed consent form\n* Subject agrees to return for all follow-up evaluations for the duration of the study (i.e.,. geographically stable)\n\nExclusion Criteria:\n\n* The subject has pre-existing valve prosthesis in the aortic position\n* The subject's aortic valve morphology is not tri-leaflet\n* The subject has active endocarditis\n* Heavily calcified valves\n* The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis\n* Leukopenia\n* Acute anemia (Hb \\< 9mg%)\n* Platelet count \\<100,000 cell/mm3\n* Need for emergency surgery for any reason\n* History of bleeding diathesis or coagulopathy or the subject refuses blood transfusions\n* Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 4 weeks after discontinuation of antibiotics)\n* Subjects in whom transesophageal echocardiography (TEE) is contraindicated\n* Low Ejection Fraction (EF) EF \\< 35%\n* Life expectancy \\< 1 year\n* The subject is or will be participating in a concomitant research study of an investigational product or has participated in such a study within the 30 days prior to screening\n* The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent\n* The subject is pregnant or lactating\n* Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)\n* Myocardial Infarction (MI) within one month of trial inclusion\n* The subject has a known intolerance to titanium or polyester\n* The subject has documented unstable or \\> 2 vessel coronary disease\n* The subject requires additional valve replacement or valve repair"}, 'identificationModule': {'nctId': 'NCT01732835', 'briefTitle': 'The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biostable Science & Engineering'}, 'officialTitle': 'The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve', 'orgStudyIdInfo': {'id': 'TP-01-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HAART 300 Annuloplasty Device', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair', 'interventionNames': ['Device: HAART 300 Annuloplasty Device']}], 'interventions': [{'name': 'HAART 300 Annuloplasty Device', 'type': 'DEVICE', 'description': 'Implantation of HAART 300 Annuloplasty Device for aortic valve repair', 'armGroupLabels': ['HAART 300 Annuloplasty Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '140 21', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Institute of Clinical and Experimental Medicine', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '80636', 'city': 'Berlin', 'country': 'Germany', 'facility': 'German Heart Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Uniklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Klinik für Herz und Gefässchirurgie', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Herz- und Gefäßchirurgie', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School (MHH)', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'München', 'country': 'Germany', 'facility': 'Munchen Heart Center', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '90471', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Klinikum Nürnberg Süd', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}], 'overallOfficials': [{'name': 'Dominico Mazzitelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Munchen Heart Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biostable Science & Engineering', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}