TTVR Early Feasibility Study

March 6, 2026 updated by: Medtronic Cardiovascular

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham (UAB) Hospital
        • Principal Investigator:
          • Mustafa Ahmed, MD
        • Contact:
        • Principal Investigator:
          • Clifton Lewis, MD
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Abrazo Arizona Heart Hospital
        • Principal Investigator:
          • Timothy Byrne, MD
        • Principal Investigator:
          • Merick Kirshner, MD
        • Contact:
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Principal Investigator:
          • Raj Makkar, MD
        • Principal Investigator:
          • Wen Cheng, MD
        • Contact:
      • San Francisco, California, United States, 94115
        • Recruiting
        • California Pacific Medical Center
        • Contact:
        • Principal Investigator:
          • Christian Spies, MD
        • Principal Investigator:
          • Brett Sheridan, MD
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Principal Investigator:
          • Robert Hagberg, MD
        • Principal Investigator:
          • Talhat Azemi, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Principal Investigator:
          • Adam Greenbaum, MD
        • Contact:
        • Principal Investigator:
          • Gaetano Paone, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System - University Hospital
        • Principal Investigator:
          • Stanley Chetcuti, MD
        • Principal Investigator:
          • Steven Bolling, MD
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health
        • Principal Investigator:
          • William Merhi, MD
        • Principal Investigator:
          • Stephane Leung, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Vinayak Bapat, MD
        • Principal Investigator:
          • Konstantinos Voudris, MD
    • Montana
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Providence Saint Patrick Hospital
        • Contact:
        • Principal Investigator:
          • Daniel Spoon, MD
        • Principal Investigator:
          • Travis Abicht, MD
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • The Mount Sinai Hospital
        • Principal Investigator:
          • Samin Sharma, MD
        • Principal Investigator:
          • David Adams, MD
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • New York-Presbyterian Hospital Columbia University Medical Center
        • Principal Investigator:
          • Susheel Kodali, MD
        • Principal Investigator:
          • Isaac George, MD
        • Contact:
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Azeem Latib, MD
        • Contact:
        • Principal Investigator:
          • Tadahisa Sugiura, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • The Christ Hospital
        • Principal Investigator:
          • Geoffrey Answini, MD
        • Principal Investigator:
          • Puvi Seshiah, MD
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Anene C Ukaigwe, MD
        • Contact:
        • Principal Investigator:
          • Yasir Abu-Omar, MD
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Riverside Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Steven Yakubov, MD
        • Principal Investigator:
          • Steven Duff, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University Hospital
        • Principal Investigator:
          • Firas Zahr, MD
        • Principal Investigator:
          • Howard Song, MD
        • Contact:
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Recruiting
        • UPMC Pinnacle Harrisburg Campus
        • Principal Investigator:
          • Mubashir Mumtaz, MD
        • Principal Investigator:
          • Arun Kanmanthareddy, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Principal Investigator:
          • Sachin Goel, MD
        • Principal Investigator:
          • Michael Reardon, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53125
        • Recruiting
        • Aurora Saint Lukes Medical Center
        • Principal Investigator:
          • Tanvir Bajwa, MD
        • Principal Investigator:
          • William Fischer, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary Cohort
Device: Intrepid TTVR System
Device: Intrepid™ TTVR System
Device: Intrepid™ TTVR System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through 30 days post-procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2031

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT20009TMV003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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