Tricuspid Valve Replacement for Tricuspid Regurgitation

Recruiting at 21 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?

This trial explores a new treatment called the Intrepid TTVR System, designed to replace a faulty tricuspid valve in the heart using a less invasive method. The goal is to evaluate how well this method works for individuals with severe tricuspid regurgitation, a condition where the heart's valve doesn't close properly, causing symptoms like fatigue and shortness of breath. Suitable candidates are those whose symptoms persist despite medication and who have been advised by their doctors that they are at high risk for traditional surgery. As an unphased trial, this study offers patients the opportunity to contribute to groundbreaking research that could lead to innovative treatment options.

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 prior data suggests that the Intrepid TTVR System is safe for tricuspid valve replacement?

Research has shown that the Intrepid transcatheter tricuspid valve replacement (TTVR) system holds promise for patients with tricuspid regurgitation, a condition where the heart's tricuspid valve doesn't close properly. In a study involving 643 patients, the TTVR system succeeded in 94% of cases.

Another study found that one year after the procedure, 90.1% of patients remained alive, and 88.4% had not been hospitalized for heart failure. Additionally, 97.6% of patients experienced only mild or no symptoms post-procedure. These results suggest that the treatment is generally safe and carries a low risk of serious side effects.

However, as this is an early study, further research is necessary to confirm these findings. Discussing potential risks with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Intrepid TTVR System is unique because it offers a minimally invasive approach to replacing the tricuspid valve, which is a significant shift from the traditional open-heart surgery currently used to treat tricuspid regurgitation. Unlike surgical valve replacement, which involves large incisions and longer recovery times, the Intrepid TTVR System is designed to be delivered via a catheter, allowing for a less invasive procedure. Researchers are excited about this treatment because it has the potential to reduce recovery time and hospital stays, making it a safer and more convenient option for patients who may not tolerate open-heart surgery well.

What evidence suggests that the Intrepid TTVR System is effective for tricuspid regurgitation?

Research has shown that the Intrepid transcatheter tricuspid valve replacement (TTVR) system, which participants in this trial will receive, may help treat tricuspid regurgitation, a condition where the heart's tricuspid valve doesn't close properly. A study presented at PCR London Valves 2022 found that 90.1% of patients were alive after one year, and 88.4% did not need hospitalization for heart failure. Additionally, 97.6% of patients experienced only mild or no symptoms of valve leakage after receiving the Intrepid TTVR. These results suggest the treatment could effectively reduce symptoms and improve patient health. However, further evaluation of safety concerns remains necessary. ^{2 4 5 6 7}

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 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) 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04433065

Study Details | NCT04433065 | TTVR Early Feasibility Study The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772930323012036

The Current Landscape of Transcatheter Tricuspid Valve ... More recently, 1-year outcomes were presented at PCR London Valves 2022, with 90.1% survival, 88.4% freedom from heart failure hospitalizations, 97.6% with mild ...

3. sutterhealth.org sutterhealth.org/research/clinical-trials/structural-heart-ttvr-intrepid-1049141836

Structural Heart TTVR - INTREPID The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement ...

4. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1562658/full

Transcatheter tricuspid valve replacement: will it prevail? Although most patients experienced a significant reduction in regurgitation severity, the incidence of important safety outcomes also warrants attention, ...

5. news.medtronic.com news.medtronic.com/2020-09-09-Medtronic-Receives-Breakthrough-Device-Designation-from-FDA-Begins-Early-Feasibility-Study-for-Investigational-Intrepid-TM-Transcatheter-Valve-System-for-the-Treatment-of-Tricuspid-Valve-Regurgitation

Medtronic Receives Breakthrough Device Designation ... The Intrepid transcatheter valve is the same valve being evaluated for the treatment of symptomatic mitral valve regurgitation in the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12183386/

Efficacy and Safety of Transcatheter Tricuspid Valve ... Twenty‐one studies with 643 patients (mean age 75.8 years, 70.76% female) reported a 94% technical success rate for TTVR (95% CI: 91–96%). 30‐ ...

7. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/INTREPID-TTVR

Tricuspid Regurgitation: Study of the TTVR Transfemoral System This study focuses on individuals who have tricuspid regurgitation (TR), a condition in which the heart's tricuspid valve does not close tightly.