Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-02 @ 12:31 PM
Study NCT ID:
NCT05685303
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-23
First Post:
2022-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alleviant ALLAY-HF 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': 500}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2032-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2022-12-14', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Primary Endpoint', 'timeFrame': '12-month', 'description': 'The primary endpoint is a composite of mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%\n2. NYHA Class II, III or ambulatory IV\n3. Exercise right heart catheterization\\*\n\n 1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)\n 2. Exercise PVR \\< 1.8 WU\n4. Ongoing stable GDMT\n\nExclusion Criteria:\n\n1. Advanced heart failure\n2. Presence of a pacemaker\n3. Evidence of right heart dysfunction'}, 'identificationModule': {'nctId': 'NCT05685303', 'briefTitle': 'Alleviant ALLAY-HF Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alleviant Medical, Inc.'}, 'officialTitle': 'Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'CIP-0003'}}, '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': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cardiovascular Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85718', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pima Heart and Vascular', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Memorial Care Long Beach Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'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': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VA', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Santa Barbara Cottage Hospital', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '32504', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'The Cardiac and Vascular Institute (TCAVI)', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'HCA Florida Memorial Hospital', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'NCH Research Institute', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'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': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Illinois Masonic Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60540', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Cardiovascular Institute', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '62769', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Education and Research Cooperative', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'St. Elizabeth Healthcare', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'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': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medical Institution', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'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': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University - St Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'VA NY Harbor Healthcare System', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United 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'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': '73135', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'South Oklahoma Heart Research, LLC.', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': "Providence St. Vincent's Medical Center", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17101', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pinnacle Health Cardiovascular Institute', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health - Midlands', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Monument Health', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Stern Cardiovascular Foundation', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'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': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Heart', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75930', 'city': 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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}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Tbilisi Heart and Vascular', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '29549', 'city': 'Bad Bevensen', 'country': 'Germany', 'facility': 'Heart and Vascular Center-Bad Bevensen', 'geoPoint': {'lat': 53.07923, 'lon': 10.58129}}, {'zip': '29549', 'city': 'Bad Bevensen', 'country': 'Germany', 'facility': 'Herz- und Gefasszentrum Bad Bevensen', 'geoPoint': {'lat': 53.07923, 'lon': 10.58129}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'University of Gießen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '22087', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Marienkrankenhaus', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22763', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Askelepios Klinik Altona', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '76137', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'St. Vincentius Kliniken', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitatsklinikum Schleswig-Holstein (UKSH)', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Kardiologie', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '18057', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Universitatsmedizin Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'European Interbalken Medical Center', 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'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': 'James Udelson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alleviant Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}