The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System

Medtronic Cardiovascular40 sites in 1 country150 target enrollmentOctober 20, 2020

ConditionsTricuspid Regurgitation

InterventionsIntrepid™ TTVR System

Overview

Phase: N/A
Intervention: Intrepid™ TTVR System
Conditions: Tricuspid Regurgitation
Sponsor: Medtronic Cardiovascular
Enrollment: 150
Locations: 40
Primary Endpoint: Rate of implant or delivery related serious adverse events
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 20, 2020

End Date

July 30, 2031

Last Updated

last month

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Cardiovascular

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Primary Cohort

Device: Intrepid TTVR System

Intervention: Intrepid™ TTVR System

Outcomes

Primary Outcomes

Rate of implant or delivery related serious adverse events

Time Frame: Through 30 days post-procedure

Rate of implant or delivery related serious adverse events

Secondary Outcomes

Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)(During Procedure)
Change in NYHA Class from baseline(Through 30 days post-procedure)
Change in TR Grade from baseline(Through 30 days post-procedure)
Rate of no significant TV stenosis(Through 30 days post-procedure)