Tricuspid Valve Replacement for Tricuspid Regurgitation

Recruiting at 20 trial locations

Overseen By Abbey Foote

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Must be taking: Diuretics

Disqualifiers: Severe right ventricular dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During Procedure

150 Participants Needed

What You Need to Know Before You Apply

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.

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 5}

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 5}

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 6}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Intrepid TTVR System

Trial Overview The 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.

How Is the Trial Designed?

Group I: Primary Cohort Experimental Treatment 1 Intervention

Device: Intrepid TTVR System

Intrepid TTVR System is already approved in United States for the following indications:

Approved in United States as Intrepid TTVR System for:

• Severe, symptomatic tricuspid regurgitation

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials

78

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

Published Research Related to This Trial

In a study of 28 patients with severe tricuspid regurgitation, the edge-to-edge transcatheter tricuspid valve repair (TTVr) successfully reduced tricuspid regurgitation by at least one grade in all patients, demonstrating high efficacy.

At three months post-procedure, 83% of patients improved to NYHA class I or II, and only one patient experienced a minor complication, indicating that TTVr is a safe and effective treatment option for severe tricuspid regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Results after the Implementation of an Edge-To-Edge Transcatheter Tricuspid Valve Repair Program. Cepas-Guillen, PL., de la Fuente Mancera, JC., Guzman Bofarull, J., et al.[2021]

The meta-analysis of 35 studies involving 5,316 patients found that the operative mortality rate for isolated surgical tricuspid valve replacement (TVR) was 12%, with higher risks for patients operated on before 1995, those with prior cardiac surgeries, or liver disease.

Common complications following surgical TVR included pacemaker implantation (10%), bleeding (12%), acute kidney injury (15%), and respiratory issues (15%), highlighting the need for careful patient selection and management in future transcatheter tricuspid valve replacement trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of isolated tricuspid valve replacement: a systematic review and meta-analysis of 5,316 patients from 35 studies. Scotti, A., Sturla, M., Granada, JF., et al.[2023]

Transcatheter tricuspid valve replacement (TTVR) was performed successfully in 46 high-risk patients with severe tricuspid regurgitation, achieving a procedural success rate of 97.8% and significantly reducing the severity of TR after 6 months.

The procedure demonstrated a favorable safety profile, with a 6-month mortality rate of 17.4% and a significant reduction in symptoms like peripheral edema and ascites, indicating improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation. Lu, FL., An, Z., Ma, Y., et al.[2021]

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]

Transcatheter tricuspid valve replacement (TTVR) is a promising treatment for patients with severe tricuspid regurgitation, particularly those with significant annular dilation and large coaptation gaps, which are difficult to address with traditional surgery.

Most TTVR devices are still in early clinical development, but one device is currently in a pivotal trial, suggesting that TTVR could greatly improve outcomes and survival rates for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthotopic Transcatheter Tricuspid Valve Replacement. Greenbaum, AB., Babaliaros, VC., Eng, MH.[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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Initial Results after the Implementation of an Edge-To-Edge Transcatheter Tricuspid Valve Repair Program. [2021]

2. France pubmed.ncbi.nlm.nih.gov

Outcomes of isolated tricuspid valve replacement: a systematic review and meta-analysis of 5,316 patients from 35 studies. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Orthotopic Transcatheter Tricuspid Valve Replacement. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of transcatheter tricuspid valve replacement for tricuspid regurgitation on hepatic, cardiac, and venous structure. [2023]