Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT03997305
Status:
UNKNOWN
Last Update Posted:
2023-09-01
First Post:
2019-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AltaValve Early Feasibility Study Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Japan']}, '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': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2019-06-21', 'studyFirstSubmitQcDate': '2019-06-21', 'lastUpdatePostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Event', 'timeFrame': '30 days', 'description': 'Cardiac death, stroke, mitral valve related repeated intervention'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'Index procedure completion (Day 0)', 'description': 'Technical Success per MVARC criteria'}, {'measure': 'Procedural success', 'timeFrame': '30 days', 'description': 'Device success and absence of major device or procedure related serious adverse events'}, {'measure': 'Device success', 'timeFrame': '30 days', 'description': 'Device Success per MVARC criteria'}, {'measure': 'Change in MR grade', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Mitral Regurgitation', 'TMVR', 'Functional Regurgitation', 'Degenerative Regurgitation', 'Transcathether Mitral Valve Replacement', 'Primary Regurgitation', 'Secondary Regurgitation'], 'conditions': ['Mitral Regurgitation', 'Mitral Insufficiency', 'Mitral Valve Incompetence', 'Mitral Valve Regurgitation', 'Mitral Incompetence']}, 'referencesModule': {'references': [{'pmid': '41224388', 'type': 'DERIVED', 'citation': 'Genereux P, Wrobel K, Ninios V, Grygier M, Tahirkheli N, Sorajja P, Rinaldi MJ, Reardon MJ, Zembala MO, Bezerra HG, Waggoner TE, Giustino G, Waksman R, Grayburn P, Bapat V. 6-Month Outcomes of a Supra-Annular Transcatheter Mitral Valve Replacement: An Early Feasibility Study. JACC Cardiovasc Interv. 2025 Nov 10;18(21):2584-2592. doi: 10.1016/j.jcin.2025.08.040.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects ≥ 18 years of age.\n2. Subjects symptomatic New York Heart Association (NYHA) II-IV.\n3. Subjects with severe MR as documented by echo.\n4. Subjects who are at high risk for open-heart surgery as documented by the health care professional (e.g., Heart Team consisting of cardiac surgeon and interventional cardiologist in United States).\n\nAbbreviated Exclusion Criteria:\n\n1. Inability to understand the study or a history of non-compliance with medical advice.\n2. Unwilling or unable to sign the Informed Consent Form (ICF).\n3. History of any cognitive or mental health status that would interfere with study participation.\n4. Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).\n5. Female subjects who are pregnant or planning to become pregnant within the study period.\n6. Known hypersensitivity or contraindication to aspirin, heparin, or Warfarin without adequate alternative medications.\n7. Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.\n8. Known hypersensitivity to contrast media that cannot be adequately medicated.\n9. Evidence of current Left Ventricular Ejection Fraction (LVEF) ≤30% (where current is defined as the latest LVEF measurement completed within 90 days prior to the index procedure).\n10. Concurrent medical condition with a life expectancy of less than 12 months.\n11. Prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or MitraClip not interfering with AltaValve placement).'}, 'identificationModule': {'nctId': 'NCT03997305', 'briefTitle': 'AltaValve Early Feasibility Study Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': '4C Medical Technologies, Inc.'}, 'officialTitle': 'AltaValve Early Feasibility Study Protocol', 'orgStudyIdInfo': {'id': '1890'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AltaValve', 'type': 'DEVICE', 'description': 'Transcatheter Mitral Valve Replacement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ariana Ehsan, MD', 'role': 'CONTACT', 'email': 'Ariana.Ehsan@tmcaz.com', 'phone': '520-324-5207'}, {'name': 'Tom Waggoner, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'George Makdisi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tucson Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91360', 'city': 'Thousand Oaks', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mane Arabyan', 'role': 'CONTACT', 'email': 'Mane.Arabyan@hcahealthcare.com', 'phone': '805-796-3746'}, {'name': 'Saibal Kar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gregory Fontana, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Los Robles Regional Medical Center', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erin C Collins, MPH', 'role': 'CONTACT', 'email': 'erin.c.collins@medstar.net', 'phone': '202-877-6622'}, {'name': 'Ron Waksman, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christian Shults, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedStar Washington Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tatyana Harris', 'role': 'CONTACT', 'email': 'trharris1@usf.edu', 'phone': '813-250-2392'}, {'name': 'Hiram Bezerra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kostas Marmagkiolis, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lucian Lozonschi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Charles', 'role': 'CONTACT', 'email': 'elizabeth.z.charles@emory.edu', 'phone': '404-686-1249'}, {'name': 'Gaetano Paone, MD, MHSA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'George Hanzel, MD, FACC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '70360', 'city': 'Houma', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Aucoin, LPN', 'role': 'CONTACT', 'email': 'Jennifer.Aucoin@cardio.com'}, {'name': 'Peter Fail, MD, FACC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Donald Netherland, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Catherine VanZile', 'role': 'CONTACT', 'email': 'catherine.vanzile@atlantichealth.org', 'phone': '201-787-2254'}, {'name': 'Philippe Genereux, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'John Brown III, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dana Amaro, RN', 'role': 'CONTACT', 'email': 'Dana.Amaro@atriumhealth.org', 'phone': '704-355-4692'}, {'name': 'Michael Rinaldi, MD, FACC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eric Skipper, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atrium Health', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '73135', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie White', 'role': 'CONTACT', 'email': 'juliewhite@okheart.com', 'phone': '405-628-6865'}, {'name': 'Bruce Cannon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Naeem Tahirkheli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oklahoma Heart Hospital', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kari Fondren, RN', 'role': 'CONTACT', 'email': 'kari.fondren@sterncardio.com', 'phone': '901-271-4062'}, {'name': 'H. Edward Garret, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Basil M. Paulus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baptist Memorial Hospital - Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Alanis, BSN, RN-BC', 'role': 'CONTACT', 'email': 'imalanis@houstonmethodist.org', 'phone': '713-441-3629'}, {'name': 'Sachin Goel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Reardon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexandra Finley', 'role': 'CONTACT', 'email': 'Alexandra.Finley@BSWHealth.org', 'phone': '469-814-4235'}, {'name': 'Molly Szerlip, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Timothy George, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor Scott & White', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'centralContacts': [{'name': 'Adam Lawrence', 'role': 'CONTACT', 'email': 'AltaValveEFS@4CMed.com', 'phone': '+1-727-318-2203'}], 'overallOfficials': [{'name': 'Philippe Genereux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Morristown Medical Center'}, {'name': 'Vinayak Bapat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allina Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '4C Medical Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}