Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-25 @ 7:02 PM
Study NCT ID:
NCT05061004
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2021-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cephea Early Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], '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': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Endpoint', 'timeFrame': '30 days post implant', 'description': 'Freedom from all-cause mortality, which will be assessed at 30 days post implant.'}, {'measure': 'Primary Effectiveness Endpoint', 'timeFrame': '30 days post implant', 'description': 'Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Mitral Regurgitation']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria.\n* LVEF ≥ 30%\n* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.\n\nKey Exclusion Criteria:\n\n* Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.\n* Need for emergent or urgent surgery.'}, 'identificationModule': {'nctId': 'NCT05061004', 'briefTitle': 'Cephea Early Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Cephea Early Feasibility Study', 'orgStudyIdInfo': {'id': 'ABT-CIP-10354'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System', 'interventionNames': ['Device: Cephea Mitral Valve System']}], 'interventions': [{'name': 'Cephea Mitral Valve System', 'type': 'DEVICE', 'description': 'Transcatheter mitral valve replacement', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andjela Kremenovic', 'role': 'CONTACT', 'email': 'Andjela.Kremenovic@cshs.org', 'phone': '417-353-7177'}, {'name': 'Raj Makkar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Houston', 'role': 'CONTACT', 'email': 'hhouston@ucdavis.edu', 'phone': '916-734-5155'}, {'name': 'Jason Rogers, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California - Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '91360', 'city': 'Thousand Oaks', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Los Robles Regional Medical Center', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Griffith', 'role': 'CONTACT', 'email': 'Danielle.griffith@piedmont.org', 'phone': '404-605-2958'}, {'name': 'Vinod Thourani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pradeep Yadav, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lindsey Steele', 'role': 'CONTACT', 'email': 'lindsey.steele@ascension.org', 'phone': '316-268-8092'}, {'name': 'Bassem Chehab, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Via Christi Regional Medical Center - St. Francis Campus', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allison Schley', 'role': 'CONTACT', 'email': 'schleya@med.umich.edu', 'phone': '734-232-4319'}, {'name': 'Gorav Ailawadi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Nguyen', 'role': 'CONTACT', 'email': 'Jennifer.nguyen@allina.com', 'phone': '612-863-9291'}, {'name': 'Mario Goessl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Minneapolis Heart Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kate Dalton', 'role': 'CONTACT', 'email': 'keb2114@columbia.edu', 'phone': '212-342-1820'}, {'name': 'Torsten Vahl', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York-Presbyterian/Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tammy Rodriguez Guzman', 'role': 'CONTACT', 'email': 'tamrodrigu@montefiore.org', 'phone': '(718) 920-6523'}, {'name': 'Mohamed Azeem Latib, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center - Moses Division', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Montana Bright', 'role': 'CONTACT', 'email': 'montana.bright@atriumhealth.org'}, {'name': 'Michael Rinaldi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atrium Health - Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Tylicki', 'role': 'CONTACT', 'email': 'tylicke@ccf.org', 'phone': '216-444-6950'}, {'name': 'Samir Kapadia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Allegheny General Hospital - ASRI', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kolie Gasaway', 'role': 'CONTACT', 'email': 'kolie.gasaway@ascension.org', 'phone': '(615) 222-3227'}, {'name': 'Evelio Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ascension Saint Thomas', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37208', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kashish Goel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt Heart & Vascular Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deena Victor', 'role': 'CONTACT', 'email': 'dcvictor@HoustonMethodist.org'}, {'name': 'Sachin Goel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Nagel', 'role': 'CONTACT', 'email': 'jennifer.nagel@swedish.org'}, {'name': 'Sameer Gafoor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Montreal', 'state': 'Quebec', 'status': 'COMPLETED', 'country': 'Canada', 'facility': 'Institut de Cardiologie de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Institut de Cardiologie de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Jennifer Studt', 'role': 'CONTACT', 'email': 'jennifer.studt@abbott.com', 'phone': '+1 314-616-2790'}], 'overallOfficials': [{'name': 'Barathi Sethuraman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Structural Heart'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}