TTVR Early Feasibility Study

Description

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.

Conditions

Tricuspid Regurgitation

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

TTVR Early Feasibility Study

Condition
Tricuspid Regurgitation
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham (UAB) Hospital, Birmingham, Alabama, United States, 35233

Phoenix

Abrazo Arizona Heart Hospital, Phoenix, Arizona, United States, 85016

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

San Francisco

California Pacific Medical Center, San Francisco, California, United States, 94115

Atlanta

Emory University Hospital Midtown, Atlanta, Georgia, United States, 30308

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Minneapolis

Abbott Northwestern Hospital, Minneapolis, Minnesota, United States, 55407

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10467

New York

The Mount Sinai Hospital, New York, New York, United States, 10029

New York

Columbia University Medical Center/NYPH, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Cardiovascular,

Study Record Dates

2031-07-30