TTVR System for Tricuspid Regurgitation

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Laplace Interventional, Inc

Disqualifiers: Severe RV dysfunction, Stroke, others

No Placebo Group

Approved in 1 Jurisdiction

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

Trial 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 (Procedure)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Tucson Medical Center Tucson, AZ

Kaiser Permanente San Francisco, CA

Piedmont Hospital Atlanta, GA

Mayo Clinic Rochester, MN

More Trial Locations

Who Is Running the Clinical Trial?

Laplace Interventional, Inc Lead Sponsor

References

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

Initial Results after the Implementation of an Edge-To-Edge Transcatheter Tricuspid Valve Repair Program. [2021] Transcatheter tricuspid valve repair (TTVr) has emerged as an alternative for the treatment of severe tricuspid regurgitation (TR). We report our initial experience with an edge-to-edge TTVr system in a high-volume institution.

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] Transcatheter tricuspid valve replacement (TTVR) is rapidly emerging as a therapeutic option amongst patients with secondary tricuspid regurgitation. Historical data from surgical tricuspid valve replacement (TVR) studies may serve as a benchmark for the development of TTVR trials.

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

Transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation. [2021] Tricuspid regurgitation (TR) is a common valvular heart disease with unsatisfactory medical therapeutics and high surgical mortality. The present study aims to evaluate the safety and effectiveness of transcatheter tricuspid valve replacement (TTVR) in high-risk patients with severe TR.

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

Characterization of Screen Failures Among Patients Evaluated for Transcatheter Tricuspid Valve Repair (TriSelect-Study). [2023] Transcatheter tricuspid valve repair (TTVr) has significantly expanded treatment options for tricuspid regurgitation (TR). However, a sizeable proportion of patients are still declined for TTVr and little is known about their clinical characteristics and cardiac morphology.

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] Transcatheter tricuspid valve repair (TTVR) is a promising technique for the treatment of tricuspid regurgitation (TR). Data comparing the performance of novel edge-to-edge devices (PASCAL and MitraClip-XTR) are scarce.