Transcatheter Mitral Valve Repair for Mitral Valve Regurgitation

(CLASP Trial)

No longer recruiting at 17 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Right heart failure, Intracardiac mass, others

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

Compensation: Varies

Number of Visits: 31

Duration: Immediate (procedure duration)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called the Edwards PASCAL Transcatheter Mitral Valve Repair System. The goal is to assess its safety and effectiveness for individuals with moderate-to-severe or severe mitral valve regurgitation, a condition where the heart's mitral valve doesn't close tightly, causing blood to flow backward. This trial may suit those with heart failure who experience symptoms like shortness of breath or fatigue despite treatment and have been informed of significant mitral valve leakage. As an unphased trial, it offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that the Edwards PASCAL Transcatheter Mitral Valve Repair System is safe?

Research has shown that the Edwards PASCAL Transcatheter Mitral Valve Repair System is generally well-tolerated. Results from the CLASP IID Trial and Registry indicate good survival rates and a lasting reduction in mitral regurgitation, a condition where blood leaks backward through the mitral valve. Over two years, patients experienced positive outcomes without major safety concerns.

Additionally, one-year results from an early compassionate use study showed a low rate of heart failure hospitalizations at just 6%. Only one patient required further surgery within a year, suggesting the treatment is quite safe. Overall, these studies suggest the treatment is safe for people with mitral valve issues, with few serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Edwards PASCAL Transcatheter Mitral Valve Repair System is unique because it offers a less invasive approach to fixing mitral valve regurgitation compared to traditional surgery. Unlike standard surgical options like open-heart surgery, this system uses a catheter-based method, allowing doctors to repair the valve without needing to open the chest. This minimally invasive technique can reduce recovery time and lower the risk of complications, making it an exciting option for patients who are not ideal candidates for surgery. Researchers are particularly interested in how this system can improve patient outcomes and provide a safer alternative for those with severe mitral valve issues.

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

Research shows that the Edwards PASCAL Transcatheter Mitral Valve Repair System, which participants in this trial will receive, effectively repairs a leaky heart valve, known as mitral valve regurgitation. Studies indicate that this treatment significantly reduces valve leakiness. For example, after one year, 98% of patients experienced a reduction to mild or moderate levels, with most seeing even better results. Results after two years also remain encouraging, with good survival rates and continued improvement in heart function. This evidence suggests that the PASCAL system is a dependable choice for patients needing this type of heart repair. ^{1 3 6 7 8}

Who Is on the Research Team?

Molly Szerlip, MD

Principal Investigator

The Heart Hospital Baylor

Gideon Cohen, MD

Principal Investigator

Sunnybrook Hospital

Ulrich Schafer, MD

Principal Investigator

BundeswehrZentralkrankenhaus Koblenz

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure symptoms despite treatment, who are candidates for mitral valve repair or replacement. They must have significant mitral valve regurgitation confirmed by specific heart imaging tests and a sufficiently large mitral valve area. People can't join if they have certain right-sided heart issues, life expectancy under 12 months, participation in other trials without reaching the primary endpoint, guardianship status, unsuitable leaflet anatomy for the device implantation or a small mitral valve area.

Inclusion Criteria

My heart team has approved me for mitral valve surgery.

I have been diagnosed with serious mitral valve leakage.

My heart condition limits my physical activity despite treatment.

Exclusion Criteria

You have a mass, blood clot, or infection in your heart as seen on an echocardiogram.

I have severe right-sided heart failure confirmed by a heart ultrasound.

Your mitral valve area is less than 4.0 cm². If it can't be measured directly, a different measurement is acceptable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Edwards PASCAL Transcatheter Mitral Valve Repair procedure

Immediate (procedure duration)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Regular visits at 30 days, 6 months, 1 year, 2 years, and 3 years

Long-term follow-up

Annual monitoring for reintervention rates and major adverse events

Annually after 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Edwards PASCAL Transcatheter Mitral Valve Repair System

Trial Overview The study is evaluating the Edwards PASCAL Transcatheter Mitral Valve Repair System's safety and effectiveness in improving clinical outcomes for patients with serious mitral valve regurgitation—a condition where blood leaks backward into the heart due to a faulty valve.

How Is the Trial Designed?

Group I: Edwards PASCAL Transcatheter Mitral Valve Repair System Experimental Treatment 1 Intervention

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 low major adverse event rate of 6.5% and an all-cause mortality rate of only 1.6% in 62 patients with severe mitral regurgitation, indicating its safety for use in this population.

At 30 days post-procedure, 98% of patients experienced a significant reduction in mitral regurgitation severity, and there were notable improvements in functional status and quality of life, as evidenced by increased walking distance and higher scores on quality of life assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. Lim, DS., Kar, S., Spargias, K., et al.[2020]

The PASCAL system for transcatheter mitral valve repair demonstrated a high technical success rate of 96% in 68 patients, with all patients achieving a reduction in mitral regurgitation (MR) to ≤2+ at discharge.

At 30 days post-procedure, the major adverse event rate was low at 5.9%, and 98% of patients improved to New York Heart Association functional class ≤II, indicating both safety and significant improvement in patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation. Li, CP., Estévez-Loureiro, R., Freixa, X., et al.[2022]

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]

The PASCAL system for percutaneous mitral valve repair demonstrated a high technical success rate of 90% in 41 patients with severe mitral regurgitation, with 97% of patients maintaining a low MR grade (≤2) at an average follow-up of 8.7 months.

The procedure was found to be safe, with a low rate of major adverse events (3%) and significant improvements in patients' functional class and heart health markers, indicating its efficacy in treating severe mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PASCAL-based mitral valve repair in an all-comer population: acute and mid-term clinical results. Schlegel, P., Crespo López, P., Kreusser, MM., et al.[2021]

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]

In a study involving 17 high-risk patients with symptomatic mitral regurgitation, the PASCAL Ace implant system achieved a technical success rate of 100% and a procedural success rate of 94%, indicating its effectiveness in treating this condition.

After one year, 93% of patients had a significant reduction in mitral regurgitation severity (to grade ≤2+), with an 88% survival rate and 94% free from heart failure hospitalization, demonstrating both safety and efficacy of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair. Moonen, A., Chuang, A., Simmons, L., et al.[2023]

The Edwards PASCAL TMVr system demonstrated a high technical success rate of 96% in treating severe mitral regurgitation in a cohort of 23 high-risk patients, with significant reduction in regurgitation severity after the procedure.

At 30 days post-implantation, 78% of patients achieved device success, and 95% of those alive reported improved heart function, indicating the system's efficacy despite the complexity of their conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study. Praz, F., Spargias, K., Chrissoheris, M., et al.[2018]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jcin.2025.07.014

CLASP IID Trial and Registry: 2-Year Outcomes of ... Two-year outcomes from the CLASP IID Trial and Registry show favorable survival, and significant and sustained MR reduction with functional and ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.031881

One‐Year Outcomes According to Mitral Regurgitation ... This study reports 1-year outcomes of mitral valve transcatheter edge-to-edge repair with the PASCAL system according to MR etiology in a large all-comer ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10236790/

One-Year Outcomes of Early, Compassionate Use of the ... The aim of this study is to report 1-year outcomes from the early, compassionate-use observational experience with the novel PASCAL Ace implant system.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1936879824004692

Mitral Valve Transcatheter Edge-to-Edge Repair: 1-Year ... MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < ...

5. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2022/09/16/03/09/CLASP-II-D

Edwards PASCAL TrAnScatheter Valve RePair System ... The CLASP IID trial showed that transcatheter mitral edge-to-edge repair with the PASCAL system is noninferior to MitraClip for major adverse events.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1936879825018631

CLASP IID Trial and Registry: 2-Year Outcomes of ... Two-year outcomes from the CLASP IID Trial and Registry show favorable survival, and significant and sustained MR reduction with functional and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03170349

The CLASP Study Edwards PASCAL TrAnScatheter Mitral ... The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

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 ...