TTVR Early Feasibility Study
- Conditions
- Tricuspid Regurgitation
- Interventions
- Device: Intrepid™ TTVR System
- Registration Number
- NCT04433065
- Lead Sponsor
- Medtronic Cardiovascular
- Brief Summary
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
- Detailed Description
Multi-center, prospective, non-randomized, investigational, and pre-market.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
- Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
- Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
- New York Heart Association (NYHA) Function Class II or greater
- Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
- Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
- Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
- Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
- Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
- Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
- Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
- Echocardiographic evidence of severe right ventricular dysfunction
- Left ventricular ejection fraction (LVEF) <30 as measured by resting echocardiogram within 30 days of the Index Procedure
- Need for emergent or urgent surgery
- Untreated clinically significant coronary artery disease requiring revascularization
- Carcinoid tricuspid regurgitation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Primary Cohort Intrepid™ TTVR System Device: Intrepid TTVR System
- Primary Outcome Measures
Name Time Method Rate of implant or delivery related serious adverse events Through 30 days post-procedure Rate of implant or delivery related serious adverse events
- Secondary Outcome Measures
Name Time Method Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC) During Procedure For procedural success to be present, device success must have been achieved without major clinical complications as detailed per clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement (part 2: endpoint definitions)
Change in NYHA Class from baseline Through 30 days post-procedure Change in NYHA Class from baseline
Change in TR Grade from baseline Through 30 days post-procedure Change in TR Grade from baseline
Rate of no significant TV stenosis Through 30 days post-procedure Rate of no significant TV stenosis
Trial Locations
- Locations (20)
University of Alabama at Birmingham (UAB) Hospital
🇺🇸Birmingham, Alabama, United States
Abrazo Arizona Heart Hospital
🇺🇸Phoenix, Arizona, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Providence Saint Patrick Hospital
🇺🇸Missoula, Montana, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
OhioHealth Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
UPMC Pinnacle Harrisburg Campus
🇺🇸Harrisburg, Pennsylvania, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Aurora St. Lukes Medical Center
🇺🇸Milwaukee, Wisconsin, United States