Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-02 @ 4:43 AM
Study NCT ID:
NCT07116551
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'From start of procedure up to end of procedure', 'description': 'Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system.'}, {'measure': 'Device success', 'timeFrame': '30 days', 'description': 'Intended performance of the valve'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Balloon Expandable TAVI', 'TAVI', 'Treatment of patient with symptomatic severe aortic valve stenosis', 'aortic stenosis', 'cardiovascular disease'], 'conditions': ['Symptomatic Severe Aortic Stenosis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.", 'detailedDescription': "The EFS will evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is at least 18 years of age\n* Subject is able and willing to return for required follow-up visits and assessments\n* Degenerative severe aortic valve stenosis of the native aortic valve with echo-derived criteria\n\nExclusion Criteria:\n\n* Pregnant or nursing subjects\n* Life expectancy for a condition other than aortic stenosis is less than 2 years\n* Presence of other anatomic or comorbid conditions\n* Incapacitated individuals\n* Evidence of an acute myocardial infarction\n* Untreated clinically significant coronary artery disease requiring revascularization\n* Liver failure\n* Severe mitral regurgitation or severe mitral stenosis\n* etc.'}, 'identificationModule': {'nctId': 'NCT07116551', 'briefTitle': "Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis", 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': "Abbott BE TAVI Early Feasibility Study: Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis", 'orgStudyIdInfo': {'id': 'ABT-CIP-10541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BE TAVI System', 'description': 'BE TAVI System', 'interventionNames': ['Device: Abbott BE TAVI System']}], 'interventions': [{'name': 'Abbott BE TAVI System', 'type': 'DEVICE', 'description': 'Abbott BE TAVI System', 'armGroupLabels': ['BE TAVI System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bassem Chehab, Doctor', 'role': 'CONTACT', 'email': 'bassemchehab@me.com'}, {'name': 'Bassem Chehab, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Via Christi Regional Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vinayak Bapat, Doctor', 'role': 'CONTACT', 'email': 'vnbapat@yahoo.com'}, {'name': 'Vinayak Bapat, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Susheel Kodali, Doctor', 'role': 'CONTACT', 'email': 'sk2427@cumc.columbia.edu'}, {'name': 'Susheel Kodali, Doctor', 'role': 'CONTACT'}], 'facility': 'Columbia University Medical Center/New York-Presbyterian', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mohamed Azeem Latib, Doctor', 'role': 'CONTACT', 'email': 'mlatib@montefiore.org'}, {'name': 'Mohamed Azeem Latib, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center - Moses Division', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'George Galoussian', 'role': 'CONTACT', 'email': 'george.galoussian@abbott.com', 'phone': '+1 818 49 32 156'}, {'name': 'Nels Engblom', 'role': 'CONTACT', 'email': 'nels.engblom1@abbott.com', 'phone': '+1 319 853 3946'}], 'overallOfficials': [{'name': 'Ashish Oza', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Structural Heart'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}