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~8 spots leftby Jul 2025

Tricuspid Valve Replacement for Tricuspid Regurgitation

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medtronic Cardiovascular

Must be taking: Diuretics

Disqualifiers: Severe right ventricular dysfunction, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants must be symptomatic despite medical therapy, including a required diuretic, suggesting that some medications may need to be continued.

What data supports the effectiveness of the Intrepid TTVR System treatment for tricuspid regurgitation?

Research shows that transcatheter tricuspid valve replacement (TTVR) is a promising option for patients with severe tricuspid regurgitation, especially those at high risk for surgery. Studies suggest that TTVR can significantly improve the condition and survival of patients with this heart valve problem.¹ ² ³ ⁴ ⁵

Is the Intrepid TTVR System safe for humans?

The Intrepid TTVR System, used for replacing the tricuspid valve in patients with severe tricuspid regurgitation, is considered a promising alternative to open-heart surgery. Studies suggest it is generally safe for high-risk patients, although specific safety data is still emerging.¹ ² ³ ⁴ ⁶

How is the Intrepid TTVR System treatment different from other treatments for tricuspid regurgitation?

The Intrepid TTVR System is unique because it offers a minimally invasive alternative to open-heart surgery for treating tricuspid regurgitation, which is a condition with limited effective medical treatments and high surgical risks. This system is designed to replace the tricuspid valve without the need for traditional surgery, potentially reducing recovery time and complications.¹ ² ³ ⁴ ⁶

Research Team

Eligibility Criteria

This trial is for people with moderate to severe heart valve disease (tricuspid regurgitation) who are still symptomatic despite medication. Candidates must be suitable for the Intrepid TTVR system and able to undergo a procedure through the thigh vein. They should commit to follow-up visits, have an acceptable risk level for valve surgery as assessed by their medical team, and not expect any non-heart related health issues to limit their life span under two years.

Inclusion Criteria

My doctors agree I need a new heart valve despite medication.

I have severe heart valve issues confirmed by heart scans.

My heart condition limits my physical activity.

See 4 more

Exclusion Criteria

I have stents or an IVC filter that might interfere with certain medical procedures.

Your heart's pumping ability, as measured by a special heart ultrasound, is less than 30%.

I have a heart valve issue due to carcinoid syndrome.

See 6 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the transcatheter tricuspid valve replacement procedure using the Intrepid TTVR System

During Procedure

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including assessment of adverse events and changes in NYHA Class and TR Grade

4 weeks

Treatment Details

Interventions

Intrepid TTVR System (Bioprosthetic Valve)

Trial OverviewThe study tests the Intrepid transcatheter tricuspid valve replacement (TTVR) system's performance in replacing the heart's tricuspid valve via a leg vein without open-heart surgery. It aims to provide early clinical insights into how well this minimally invasive approach works.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Primary CohortExperimental Treatment1 Intervention

Device: Intrepid TTVR System

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials

Recruited

37,300+

Geoff Martha

Medtronic Cardiovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kendra J. Grubb

Medtronic Cardiovascular

Chief Medical Officer

MD from Emory University

Findings from Research

In a study of 80 patients with symptomatic tricuspid regurgitation treated with either the PASCAL or MitraClip-XTR device, both systems showed similar effectiveness in reducing TR severity, with 91% of PASCAL patients and 96% of MitraClip-XTR patients achieving at least a one-grade reduction at 30 days.

Both devices were found to be safe, with no periprocedural deaths and comparable 30-day and 3-month mortality rates, indicating that TTVR is a viable option for high-surgical-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis.Sugiura, A., Vogelhuber, J., Öztürk, C., et al.[2021]

In a study of 22 patients with severe tricuspid regurgitation (TR), transcatheter tricuspid valve replacement (TTVR) led to significant reductions in liver and heart volumes after 6 months, indicating positive remodeling effects.

The left hepatic lobe volume decreased significantly, and there was a notable reduction in right atrial volume, suggesting that TTVR can effectively reverse the adverse effects of TR on hepatic and cardiac structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of transcatheter tricuspid valve replacement for tricuspid regurgitation on hepatic, cardiac, and venous structure.Ning, X., Cao, J., Wang, W., et al.[2023]