Transcatheter Valve Repair for Tricuspid Regurgitation

(CLASP TR EFS Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System for treating tricuspid regurgitation, a heart valve issue causing backward blood flow in the heart. It targets individuals with severe tricuspid regurgitation who continue to experience symptoms despite medication. A team of heart specialists at the local site must determine that this non-surgical valve repair is suitable for the patient. The trial aims to assess whether the device can safely improve symptoms. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that the Edwards PASCAL Transcatheter Valve Repair System is safe for tricuspid regurgitation?

Research has shown that the Edwards PASCAL Transcatheter Valve Repair System is generally safe for treating tricuspid regurgitation. One study found low complication rates and high survival rates over one year. Patients experienced significant improvements in heart health and overall well-being.

However, some risks exist. Another study reported that about 17% of patients experienced a major adverse event, with hospitalization due to heart failure being the most common. Despite these risks, the treatment shows promise in effectively managing the condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Edwards PASCAL Transcatheter Valve Repair System is unique because it offers a minimally invasive approach to treating tricuspid regurgitation, a condition where the heart's tricuspid valve doesn't close tightly. Traditional treatments often involve open-heart surgery, which carries significant risks and recovery time. This system allows for valve repair via a catheter, reducing the need for major surgery and potentially speeding up recovery. Researchers are excited about this treatment because it provides a less invasive option that could lead to quicker patient recovery and fewer complications compared to standard surgical procedures.

What evidence suggests that the Edwards PASCAL Transcatheter Valve Repair System is effective for tricuspid regurgitation?

Research has shown that the Edwards PASCAL Transcatheter Valve Repair System effectively treats tricuspid regurgitation (TR), a condition where the heart's tricuspid valve leaks. One study found that a year after the procedure, 86% of patients experienced only mild or moderate TR, indicating significant reduction in valve leakage. Another study in Europe confirmed the system's safety and effectiveness, with improvements observed in just 30 days. In this trial, participants will receive treatment with the Edwards PASCAL system, a promising option for individuals with severe TR, offering lasting benefits and improved heart function. ^{4 6 7 8 9}

Who Is on the Research Team?

Susheel K. Kodali, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacc.2023.02.049

1-Year Outcomes of Transcatheter Tricuspid Valve Repair One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36378678/

Transcatheter valve repair of tricuspid regurgitation with the ... Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735109724099558

1-Year Results From a Large European Real-World Registry The PASCAL system effectively treats severe TR in high-risk patients, offering sustained TR reduction and significant clinical improvements at 1-year follow-up.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04614402

NCT04614402 | Transcatheter Repair of Tricuspid ... The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, ...

5. edwards.com edwards.com/patients-care-partners/trial/clasp-ii-tr-trial

The CLASP II TR trial for tricuspid regurgitation This trial is intended to evaluate the safety and effectiveness of the Edwards PASCAL system with optimal medical therapy (OMT) compared to OMT alone in ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0735109723050180

1-Year Outcomes of Transcatheter Tricuspid Valve Repair The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37137586/

1-Year Outcomes of Transcatheter Tricuspid Valve Repair The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of ...

8. edwards.com edwards.com/healthcare-professionals/products-services/transcatheter-mitral-tricuspid-technologies/pascal-precision-system

The PASCAL Precision system Three-year outcomes for the transcatheter repair in patients with mitral regurgitation from the CLASP study. ... Edwards PASCAL Precision Transcatheter Valve ...

9. scai.org scai.org/tricuspid-valve-repair-edwards-pascal-transcatheter-repair-system-1-year-clasp-tr-coverage-acc22

Tricuspid Valve Repair With Edwards Pascal Transcatheter ... Mortality was 10.8%. 18 % were hospitalized for heart failure and 16.9% experienced a major adverse event, the most common adverse event was ...