Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-29 @ 12:52 AM
Study NCT ID:
NCT06812533
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-16
First Post:
2025-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alleviant ALLAY-HFrEF Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Primary Endpoint', 'timeFrame': '12-Month', 'description': 'The primary endpoint is a composite of all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LVEF ≤ 40%\n* NYHA class II, III or ambulatory IV HF\n* Receiving optimal, maximally tolerated, stable GDMT\n\nExclusion Criteria:\n\n* Advanced heart failure\n* Life-expectancy \\< 12 months\n* Evidence of right heart dysfunction'}, 'identificationModule': {'nctId': 'NCT06812533', 'briefTitle': 'Alleviant ALLAY-HFrEF Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alleviant Medical, Inc.'}, 'officialTitle': 'Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction', 'orgStudyIdInfo': {'id': 'CIP-0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.', 'interventionNames': ['Device: Alleviant ALV1 System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.', 'interventionNames': ['Other: Sham-Control']}], 'interventions': [{'name': 'Alleviant ALV1 System', 'type': 'DEVICE', 'description': 'Creation of interatrial shunt', 'armGroupLabels': ['Treatment']}, {'name': 'Sham-Control', 'type': 'OTHER', 'description': 'Cardiac imaging', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Medical Center of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinical Research Services', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Ascension Sacred Heart', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '30032', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Health Care System', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60540', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Cardiovascular Institute', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '70360', 'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'University Medical Center New Orleans', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University - St Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11794', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14621', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester General Hospital', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospital', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'NC Heart and Vascular Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'ProMedica Toledo Hospital', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '17101', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pinnacle Health Cardiovascular Institute', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Monument Health', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37934', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennova Healthcare - Turkey Creek Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '79601', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'Hendrick Health', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia Research Foundation', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Heart', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '76712', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'NextStage Clinical Research', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Carilion Clinic', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLV Hospital', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint Jan Brugge', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': 'L3Y 2P6', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Southlake Regional Hospital Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'H2X 0C1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre hospitalier de l'Universite de Montreal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2X 0C1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Integre Universitaire de Sainte et de Services Scoiiaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'country': 'Canada', 'facility': 'IUCPQ - Université Laval (Quebec)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Tbilisi Heart and Vascular', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Uniwesytecki Szpital Kliniczny', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario A Coruna', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebron University Hospital Barcelona", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28222', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Salamanca', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Valencia Hospital Clinico', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Gregg Stone', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'James Udelson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alleviant Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}