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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

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

Research shows that transcatheter tricuspid valve replacement (TTVR) is emerging as a promising treatment for severe tricuspid regurgitation, especially in high-risk patients who may not be suitable for surgery. Historical data from surgical tricuspid valve replacement studies provide a benchmark, suggesting that TTVR could be a safer and effective alternative. ^{1 2 3 4 5}

Is the TTVR System for Tricuspid Regurgitation safe for humans?

The safety of the transcatheter tricuspid valve replacement (TTVR) system has been evaluated in high-risk patients with severe tricuspid regurgitation, indicating it is a promising option for those who may not be suitable for surgery. ^{1 2 3 4 5}

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

The Laplace TTVR System is unique because it is a transcatheter procedure, meaning it is less invasive than traditional surgery, which involves opening the chest. This system is designed for patients with severe tricuspid regurgitation who are at high risk for surgical complications, offering a safer alternative with potentially lower mortality rates. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

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. United States pubmed.ncbi.nlm.nih.gov

Characterization of Screen Failures Among Patients Evaluated for Transcatheter Tricuspid Valve Repair (TriSelect-Study). [2023]

5. 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]