TTVR System for Tricuspid Regurgitation

Recruiting at 5 trial locations

Overseen By Julie Messer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laplace Interventional, Inc

Disqualifiers: Severe RV dysfunction, Stroke, 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

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and practicality of a new device called the Laplace TTVR System, designed to assist individuals with severe tricuspid regurgitation, a heart valve problem that causes blood to flow backward. The trial will evaluate whether replacing the faulty valve with a new one can improve symptoms. It seeks participants who continue to experience symptoms despite treatment and have been evaluated by their heart team. This trial may suit those who have struggled with severe tricuspid valve issues even after trying other medical treatments.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

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, since participants must have been on optimal medical therapy for at least 30 days before the study, it seems likely that you can continue your current medications.

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

Research shows that the Laplace TTVR System, a treatment for tricuspid regurgitation (a condition where the heart's tricuspid valve doesn't close properly), is safe. One study used the system on 46 high-risk patients with severe tricuspid regurgitation, and the procedure was completed successfully without major issues.

Another report notes that patients experienced significant improvements in symptoms and organ function after using the Laplace TTVR System. These findings suggest that the treatment is well-tolerated and can lead to positive health outcomes. Potential trial participants should discuss the risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Laplace TTVR System is unique because it offers a transcatheter approach to replacing the tricuspid valve, which is less invasive compared to traditional open-heart surgery. Unlike current treatments, such as medical management with diuretics or surgical repair, the Laplace system directly replaces the faulty valve without needing major surgery. Researchers are excited because this method could reduce recovery time and improve outcomes for patients with tricuspid regurgitation by providing a more direct and efficient solution to valve dysfunction.

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

Research has shown that the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System may help treat tricuspid regurgitation, a condition where the heart's tricuspid valve doesn't close properly, causing blood flow problems. In one study, doctors successfully used TTVR in 46 high-risk patients, achieving a high success rate during the procedure. Early results in real-world settings indicate that this treatment can greatly improve symptoms and organ function in patients. Another study reported a 93% success rate for the procedure, suggesting that the system could effectively manage tricuspid regurgitation. These findings suggest that the Laplace TTVR System could be a good option for patients with severe tricuspid valve issues. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 22-90 with severe tricuspid regurgitation, a heart valve disease, who haven't improved after at least 30 days of optimal medical treatment. Candidates must be deemed suitable for the procedure by a heart team and agree to follow-up visits.

Inclusion Criteria

Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits

Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local heart team and confirmed by the patient selection committee. For patients with pre-existing trans-tricuspid pacemaker or ICD leads, the local heart team shall include an electrophysiologist

I have heart valve issues not improved by treatment for over 30 days.

Exclusion Criteria

Current or planned pregnancy within next 12 months for women of childbearing potential

Estimated life expectancy of less than 12 months

Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements. Any patient considered to be vulnerable

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Transcatheter replacement of the native tricuspid valve with the Laplace bioprosthesis

During procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Laplace TTVR System

Trial Overview

The study is testing the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement System, which is a new method to replace faulty heart valves without traditional surgery.

How Is the Trial Designed?

Group I: Tricuspid Valve Replacement Experimental Treatment 1 Intervention

Transcatheter replacement of the native tricuspid valve with the Laplace bioprosthesis

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

Approved in United States as Laplace TTVR System for:

• Severe or more symptomatic tricuspid regurgitation (TR) despite medical therapy

Who Is Running the Clinical Trial?

Laplace Interventional, Inc

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

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 547 patients evaluated for transcatheter tricuspid valve repair (TTVr), 41.9% were deemed unsuitable for the procedure, primarily due to anatomical issues such as right ventricular and tricuspid valve enlargement.

The findings highlight the need for earlier referral and intervention for tricuspid regurgitation, as many patients are excluded from TTVr due to clinical futility and identifiable anatomical characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of Screen Failures Among Patients Evaluated for Transcatheter Tricuspid Valve Repair (TriSelect-Study). Gerçek, M., Goncharov, A., Narang, A., 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 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]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07171060

NCT07171060 | Laplace Early Feasibility Study - Canada

Early Feasibility (EFS), prospective, single-arm, multi-center study to evaluate safety and technical feasibility of the Laplace TTVR System in ...

2.

globalcardiology.info

globalcardiology.info/site/article/view/81/186

Advancements in transcatheter tricuspid valve repair and ...

Clinical outcomes: the early feasibility study48 for the FORMA system evaluated 29 patients and showed a procedural success rate of 93%. The study reported a 50 ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40560107/

Early Outcomes of Real-World Transcatheter Tricuspid ...

Conclusions: TR elimination following TTVR in a real-world setting was associated with significant symptom and end-organ functional improvement.

4.

mayo.edu

mayo.edu/research/clinical-trials/tests-procedures/tricuspid-valve-repair-and-tricuspid-valve-replacement

Tricuspid valve repair and tricuspid valve replacement

The purpose of this study is to determine the efficacy of a strategy of rhythm control to treat severe TR due to AF, followed by early surgery.

5.

withpower.com

withpower.com/trial/phase-tricuspid-valve-incompetence-2-2024-f88ed

TTVR System for Tricuspid Regurgitation

Transcatheter tricuspid valve replacement (TTVR) was performed successfully in 46 high-risk patients with severe tricuspid regurgitation, achieving a procedural ...

6.

mayo.edu

mayo.edu/research/clinical-trials/cls-20567975

Early Feasibility Study (EFS) Laplace Transcatheter ...

About this study. The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve ...

7.

globalcardiology.info

globalcardiology.info/site/article/view/81

Advancements in transcatheter tricuspid valve repair and ...

Early feasibility study of Laplace TTVR system in patients with severe, symptomatic tricuspid regurgitation. Available from: https://www ...