Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-26 @ 11:01 AM
Study NCT ID:
NCT06342635
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydra Single-centre Experience - Copenhagen, Denmark
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary safety endpoint', 'timeFrame': '30 days', 'description': 'Early safety as defined by VARC-3, as composite of:\n\n* Freedom from all-cause mortality;\n* Freedom from all stroke;\n* Freedom from VARC 3 type 3-4 bleeding;\n* Freedom from major vascular, access-related, or cardiac structural complication;\n* Freedom from acute kidney injury stage 3 or 4;\n* Freedom from moderate or severe aortic regurgitation;\n* Freedom from new permanent pacemaker due to procedure-related conduction abnormalities;\n* Freedom from surgery or intervention related to the device.'}, {'measure': 'Primary performance endpoint', 'timeFrame': '30 days', 'description': 'Device success as defined by VARC-3, as composite of:\n\n* Technical success;\n* Freedom from mortality;\n* Freedom from surgery or intervention related to the device or to a major vascular or access related or cardiac structural complication;\n* Intended performance of the valve (mean gradient \\<20mmHg, peak velocity \\<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'Immediately after procedure'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '30 days, and 1-year'}, {'measure': 'All-cause mortality', 'timeFrame': '30 days, and 1-year'}, {'measure': 'All stroke', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Disabling stroke', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Myocardial infarction', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Major vascular complication', 'timeFrame': '30 days'}, {'measure': 'Acute kidney injury', 'timeFrame': '30 days'}, {'measure': 'New permanent pacemaker implantation due to procedure related conduction abnormalities', 'timeFrame': '30 days, and 1-year'}, {'measure': 'New-onset atrial fibrillation', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Coronary artery obstruction requiring intervention', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Re-hospitalization for procedure- or valve-related causes', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Mean aortic valve gradient', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Effective Orifice Area (EOA)', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Paravalvular leak', 'timeFrame': '30 days, and 1-year'}, {'measure': 'New York Heart Association (NYHA) functional class', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Quality-of-life evaluation', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Bioprosthetic Valve Failure (BVF)', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Bioprosthetic valve dysfunction (BVD)', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Stroke or peripheral embolism', 'timeFrame': '30 days, and 1-year'}, {'measure': 'VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns', 'timeFrame': '30 days, and 1-year'}, {'measure': 'Rates of Hypoattenuated Leaflet Thickening (HALT)', 'timeFrame': '30 days'}, {'measure': 'Rates of Reduced leaflet motion (RLM)', 'timeFrame': '30 days'}, {'measure': 'Commissural alignment', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic Valve Stenosis', 'TAVI', 'Hydra'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with severe aortic valve stenosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation\n3. Full understanding and willing to provide informed consent to study enrolment\n\nExclusion Criteria:\n\n1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)\n2. Refusal to provide informed consent to study enrolment\n3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI\n4. Patients with calcification on the annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator'}, 'identificationModule': {'nctId': 'NCT06342635', 'briefTitle': 'Hydra Single-centre Experience - Copenhagen, Denmark', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sahajanand Medical Technologies Limited'}, 'officialTitle': 'Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve', 'orgStudyIdInfo': {'id': 'HYD/DENMARK-001/2023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hydra Transcatheter Aortic Valve (THV) Series', 'type': 'DEVICE', 'description': 'The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Dr. Ole De Backer', 'role': 'CONTACT'}, {'name': 'Dr. Ole De Backer, Copenhagen University Hospital, Rigshospitalet', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Copenhagen University Hospital, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Dr. Ole De Backer', 'role': 'CONTACT', 'email': 'ole.debacker@gmail.com', 'phone': '+4527605009'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahajanand Medical Technologies Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Qmed Consulting A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}