The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System
Medtronic Cardiovascular
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.
Description
Multi-center, prospective, non-randomized, investigational, and pre-market.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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)…
Interventions
- DeviceIntrepid™ TTVR System
Device: Intrepid™ TTVR System
Locations (20)
- University of Alabama at Birmingham (UAB) HospitalBirmingham, Alabama
- Abrazo Arizona Heart HospitalPhoenix, Arizona
- Cedars Sinai Medical CenterLos Angeles, California
- California Pacific Medical CenterSan Francisco, California
- Hartford HospitalHartford, Connecticut
- Emory University Hospital MidtownAtlanta, Georgia