TTVR Early Feasibility Study

Covidien

Status

Enrolling

Conditions

Tricuspid Regurgitation

Treatments

Device: Intrepid™ TTVR System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04433065

MDT20009TMV003

Details and patient eligibility

About

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.

Full description

Multi-center, prospective, non-randomized, investigational, and pre-market.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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) 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

Exclusion criteria

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