Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-03-13 @ 5:34 PM
Study NCT ID:
NCT02732704
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-18
First Post:
2016-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2027-09-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-16', 'studyFirstSubmitDate': '2016-03-18', 'studyFirstSubmitQcDate': '2016-04-08', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-Cause Mortality at 30 days', 'timeFrame': '30 days', 'description': 'All-Cause mortality within the first 30 days post index procedure'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'At 30 days', 'description': 'Absence of procedural mortality'}, {'measure': 'Peri-Procedural Myocardial Infarction', 'timeFrame': 'At ≤72hr after the index procedure', 'description': 'Peri-procedural and spontaneous myocardial infarction'}, {'measure': 'Stroke-Free Survival', 'timeFrame': 'At 30 days and 1 year', 'description': 'Disabling or non-disabling stroke'}, {'measure': 'Bleeding & Vascular Complications', 'timeFrame': '30 days', 'description': 'Major and minor bleeding'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Aortic Valve Disease', 'Aortic Regurgitation', 'Aortic Insufficiency'], 'conditions': ['Aortic Regurgitation']}, 'referencesModule': {'references': [{'pmid': '34556282', 'type': 'DERIVED', 'citation': 'Hamid N, Ranard LS, Khalique OK, Hahn RT, Nazif TM, George I, Ng V, Leon MB, Kodali SK, Vahl TP. Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement With the JenaValve Trilogy System. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2079-2081. doi: 10.1016/j.jcin.2021.07.025. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.', 'detailedDescription': 'This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic regurgitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with severe aortic regurgitation (AR).\n* Patient at high risk for open surgical valve replacement\n* Patient symptomatic according to NYHA functional class II or higher\n* The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.\n\nExclusion Criteria:\n\n* Congenital uni or bicuspid aortic valve morphology\n* Previous prosthetic aortic valve (bioprosthesis or mechanical) implant\n* Endocarditis or other active infection\n* Need for urgent or emergent TAVR procedure for any reason\n* Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device\n* Severe mitral regurgitation'}, 'identificationModule': {'nctId': 'NCT02732704', 'briefTitle': 'THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'JenaValve Technology, Inc.'}, 'officialTitle': 'THE ALIGN-AR TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Regurgitation (AR)', 'orgStudyIdInfo': {'id': 'CP-0004'}, 'secondaryIdInfos': [{'id': 'P02C320_JV06EFS_CIP', 'type': 'OTHER', 'domain': 'JenaValve Technology Inc.'}, {'id': 'CA-0002 EU', 'type': 'OTHER', 'domain': 'JenaValve Technology Inc.'}, {'id': 'CA-0002 Germany', 'type': 'OTHER', 'domain': 'JenaValve Technology Inc.'}, {'id': 'CA-0011', 'type': 'OTHER', 'domain': 'JenaValve Technology Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcatheter Aortic Valve Replacement (TAVR)', 'description': 'TAVR with JenaValve Pericardial Valve and Delivery System', 'interventionNames': ['Device: JenaValve Pericardial TAVR System']}], 'interventions': [{'name': 'JenaValve Pericardial TAVR System', 'type': 'DEVICE', 'description': 'TAVR with JenaValve Pericardial Valve and Delivery System', 'armGroupLabels': ['Transcatheter Aortic Valve Replacement (TAVR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center Research Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'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': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Healthcare', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York-Presbyterian/ Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75201', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik GmbH Bad Nauheim', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Herzzentrum der Universität zu Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '60323', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitäres Herzzentrum Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '2333', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '3435', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '3062', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus University Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Martin B. Leon, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'New York-Presbyterian/ Columbia University Medical Center'}, {'name': 'Torsten P. Vahl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York-Presbyterian/ Columbia University Medical Center'}, {'name': 'Vinod H. Thourani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Piedmont Healthcare'}, {'name': 'Stephan Baldus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herzzentrum der Universität zu Köln'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JenaValve Technology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}