Transcatheter Valve Repair for Tricuspid Regurgitation

(CLASP TR EFS Trial)

Recruiting at 14 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Unsuitable anatomy, Previous tricuspid repair, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2-7 days

65 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Edwards PASCAL Transcatheter Valve Repair System for tricuspid regurgitation?

Research shows that the PASCAL system is effective in reducing tricuspid regurgitation (a condition where the heart's tricuspid valve doesn't close tightly) and improving patient outcomes over 12 months. Additionally, early experiences with the system for mitral valve repair (another heart valve) suggest it is a promising treatment option. ^{1 2 3 4 5}

Is the transcatheter valve repair for tricuspid regurgitation safe?

The available research does not provide specific safety data for the transcatheter valve repair for tricuspid regurgitation, but it mentions that there have been significant developments in transcatheter therapies for heart valve diseases over the last two decades, suggesting ongoing advancements in safety and effectiveness. ^{6 7 8 9 10}

How is the PASCAL Transcatheter Valve Repair System treatment different from other treatments for tricuspid regurgitation?

The PASCAL Transcatheter Valve Repair System is unique because it offers a minimally invasive option for repairing the tricuspid valve, which is particularly beneficial for patients who are at high risk for traditional surgery. This system uses a transcatheter approach, meaning it is delivered through a small tube inserted into a blood vessel, allowing for valve repair without the need for open-heart surgery. ^{1 2 3 4 11}

What is the purpose of this trial?

Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

Research Team

Susheel K. Kodali, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for individuals with severe tricuspid regurgitation (a heart valve disease) who still have symptoms despite medication. Candidates should be deemed appropriate for a non-surgical valve repair by their medical team. Those with unsuitable anatomy, conditions affecting study participation or scientific integrity, or previous tricuspid repairs are excluded.

Inclusion Criteria

I have severe valve issues in my heart.

My heart team has approved me for a specific heart valve repair procedure.

My symptoms persist despite taking medication.

Exclusion Criteria

Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

My body's structure makes me ineligible for the procedure.

I have had surgery on my tricuspid heart valve.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Edwards PASCAL Transcatheter Valve Repair System

2-7 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person)

Treatment Details

Interventions

• Edwards PASCAL Transcatheter Valve Repair System
• Transcatheter Tricuspid Valve Repair

Trial Overview The Edwards PASCAL Transcatheter Valve Repair System is being tested in this early feasibility study to see if it's safe and works well for repairing the tricuspid valve in the heart without needing open-heart surgery.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Treatment with the Edwards PASCAL Transcatheter Valve Repair System

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Findings from Research

In a study involving 235 high-risk patients with severe tricuspid regurgitation (TR), the PASCAL and PASCAL Ace systems achieved a procedural success rate of 78%, effectively reducing TR to moderate or less in 78% of patients after treatment.

At a median follow-up of 173 days, the reduction in TR was sustained, and patients experienced significant improvements in symptoms, with 63% reporting better functional status, indicating both safety and efficacy of the PASCAL systems in treating TR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Experience With the Transcatheter Leaflet Repair System for Symptomatic Tricuspid Regurgitation. Wild, MG., Löw, K., Rosch, S., et al.[2022]

The PASCAL transcatheter valve repair system demonstrated a high procedural success rate of 86% in 28 patients with severe tricuspid regurgitation, indicating its feasibility and safety for high-risk surgical patients.

At 30-day follow-up, 85% of patients had a significant reduction in tricuspid regurgitation severity, and there was a notable improvement in exercise capacity, with six-minute walk distances increasing from 240 m to 335 m.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation: A Multicenter, Observational, First-in-Human Experience. Fam, NP., Braun, D., von Bardeleben, RS., et al.[2020]

The PASCAL transcatheter valve repair system was used in 18 patients with severe mitral regurgitation, resulting in significant reductions in the severity of the condition, with 22.2% achieving complete resolution (grade 0) and 61.1% showing mild improvement (grade I).

The procedure was safe, with no periprocedural complications reported, and the device's unique features allowed for tailored repairs based on individual patient anatomy, demonstrating its efficacy in treating severe mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience. Kriechbaum, SD., Boeder, NF., Gaede, L., et al.[2021]

The PASCAL transcatheter valve repair system achieved a high procedural success rate of 96.9% in treating mitral regurgitation under conscious sedation in a study of 211 patients, indicating its efficacy as a treatment option.

The procedure resulted in significant improvements in mitral regurgitation and functional class, with a low mortality rate of 2.8% and a short hospital stay, suggesting it is a safe and efficient alternative to general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patients undergoing edge-to-edge mitral valve repair with the Edwards PASCAL transcatheter valve repair system under conscious sedation. Geisler, T., Schreieck, J., Euper, M., et al.[2023]

References

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

Multicenter Experience With the Transcatheter Leaflet Repair System for Symptomatic Tricuspid Regurgitation. [2022]

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

Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation: A Multicenter, Observational, First-in-Human Experience. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience. [2021]

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

12-Month outcomes of transcatheter tricuspid valve repair with the PASCAL system for severe tricuspid regurgitation. [2021]

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

Outcomes of patients undergoing edge-to-edge mitral valve repair with the Edwards PASCAL transcatheter valve repair system under conscious sedation. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Transcatheter Tricuspid Valve Replacement: Principles and Design. [2020]

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

Characterization of Tricuspid Valve Anatomy and Coaptation Gap in Subjects Receiving Tricuspid Transcatheter Edge-to-edge Repair: Observations from the bRIGHT TriClip™ Study. [2023]

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

Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of failed aortic bioprostheses: An evaluation of conventional redo surgery and transfemoral transcatheter aortic valve-in-valve implantation. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

How to deal with recipients of valves prone to structural failure in the 2000s: Padua experience with the TRI Technologies valve. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

Comparison of transcatheter leaflet-approximation and direct annuloplasty in tricuspid regurgitation. [2023]