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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Primary Cohort
Device: Intrepid TTVR System
Device: Intrepid™ TTVR System
Device: Intrepid™ TTVR System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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