Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 5:53 AM
Study NCT ID:
NCT03382457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-09
First Post:
2017-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Edwards Cardioband FIT Valve Repair System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid 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': 75}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2017-12-19', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate', 'timeFrame': '30 days', 'description': 'Number and percentage of patients who experienced at least one major adverse event (MAE).'}, {'measure': 'Primary Performance Endpoint - Intraprocedural Success', 'timeFrame': 'Intraprocedural', 'description': 'Number of patients who had Intraprocedural Success, definition modified from TVARC criteria. Per patient analysis.'}, {'measure': 'Primary Performance Endpoint - Clinical Success', 'timeFrame': '30 days and 1 year', 'description': 'Number of patients who had Clinical Success at 30 days and 1 year, definition modified from TVARC criteria. Per patient analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Functional', 'TR', 'FTR', 'Transcatheter', 'Repair'], 'conditions': ['Tricuspid Regurgitation']}, 'referencesModule': {'references': [{'pmid': '33744150', 'type': 'DERIVED', 'citation': 'Davidson CJ, Abramson S, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant BK, Puthumana J, Fowler D, Grayburn PA, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Deuschl F, Feldman T, Gray WA, Lim DS; Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study Investigators. Transcatheter Tricuspid Repair With the Use of 4-Dimensional Intracardiac Echocardiography. JACC Cardiovasc Imaging. 2022 Mar;15(3):533-538. doi: 10.1016/j.jcmg.2021.01.029. Epub 2021 Mar 17. No abstract available.'}, {'pmid': '33413863', 'type': 'DERIVED', 'citation': 'Davidson CJ, Lim DS, Smith RL, Kodali SK, Kipperman RM, Eleid MF, Reisman M, Whisenant B, Puthumana J, Abramson S, Fowler D, Grayburn P, Hahn RT, Koulogiannis K, Pislaru SV, Zwink T, Minder M, Dahou A, Deo SH, Vandrangi P, Deuschl F, Feldman TE, Gray WA; Cardioband TR EFS Investigators. Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes. JACC Cardiovasc Interv. 2021 Jan 11;14(1):41-50. doi: 10.1016/j.jcin.2020.10.017.'}]}, 'descriptionModule': {'briefSummary': 'Clinical Study of the Edwards Cardioband FIT Repair System', 'detailedDescription': 'The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards Cardioband FIT Repair System'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Tricuspid regurgitation (moderate or greater)\n* Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.\n* The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid reconstruction\n* Patient is willing and able to comply with all specified study evaluations and provides written informed consent\n\nKey Exclusion Criteria:\n\nPatients with conditions or anatomical considerations that preclude safe and successful procedure-related or study device access, deployment, or function, including but not limited to:\n\n* Patients in whom transesophageal echocardiography is contraindicated or cannot be completed.\n* Patients in whom tricuspid valve anatomy is not evaluable by TTE or TEE\n* Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), polyester, or contrast media.\n* Previous tricuspid valve repair or replacement with device in place\n* Presence of trans-tricuspid pacemaker or defibrillator leads where: (a)TR is a result of impingement on the tricuspid valve leaflet as evaluated by echocardiography; or (b) implanted in the RV within the last 90 days\n\nPrimary tricuspid valve disease\n\nAny physical impairment which limits the patient's capacity to complete functional testing due to other medical conditions independent of their TR (e.g., orthopedic condition)\n\nCurrently participating in another investigational biologic, drug, or device study\n\nAny of the following cardiovascular procedures:\n\n* Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days\n* Carotid surgery within the last 30 days\n* Direct current cardioversion within the last 30 days\n* Leadless RV pacemaker implant within the last 30 days\n* Cardiac surgery within the last 90 days\n\nAny of the following underlying medical conditions:\n\n* Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation\n* Active endocarditis or infection requiring antibiotic therapy (oral or intravenous)\n* Hemodynamically significant pericardial effusion\n* Significant intra-cardiac mass, thrombus, or vegetation\n* Untreated clinically significant coronary artery disease (CAD) requiring revascularization, evidence of acute coronary syndrome, or recent myocardial infarction (MI)\n* Known history of untreated severe symptomatic carotid stenosis (\\>50% by ultrasound) or asymptomatic carotid stenosis (\\>70% by ultrasound)\n* Hypotension (systolic pressure \\<90 mmHg) or requirement for inotropic support or hemodynamic support within the last 30 days\n* Known bleeding or clotting disorders or patient refuses blood transfusion\n* Active GI bleeding\n* Recent stroke\n* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months or any planned percutaneous cardiac procedure within the next 90 days\n* Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 6 months\n\nPregnant, breastfeeding, or planning pregnancy within the next 12 months\n\nConcurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator"}, 'identificationModule': {'nctId': 'NCT03382457', 'briefTitle': 'Clinical Study of Edwards Cardioband FIT Valve Repair System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'Clinical Study of Edwards Cardioband FIT Valve Repair System', 'orgStudyIdInfo': {'id': '2017-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Treatment with the Edwards Cardioband FIT Repair System', 'interventionNames': ['Device: Transcatheter Tricuspid Valve Repair']}], 'interventions': [{'name': 'Transcatheter Tricuspid Valve Repair', 'type': 'DEVICE', 'otherNames': ['Edwards Cardioband Tricuspid Valve Repair'], 'description': 'Repair of the tricuspid valve through a transcatheter approach', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center /New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97293', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lankenau Medical Center', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Heart Hospital Baylor Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'William Gray, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lankenau Heart'}, {'name': 'Firas Zahr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}