Transcatheter Mitral Valve Repair for Mitral Valve Regurgitation

(CLASP Trial)

Recruiting at 16 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)

124 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the Edwards PASCAL Transcatheter Mitral Valve Repair System treatment for mitral valve regurgitation?

The PASCAL Transcatheter Valve Repair System has shown positive results in treating mitral valve regurgitation, with studies reporting successful procedures and improvements in patients' conditions within 30 days. Additionally, early experiences with the PASCAL Ace implant system, a related technology, have demonstrated promising outcomes over one year. ^{1 2 3 4 5}

Is the Edwards PASCAL Transcatheter Mitral Valve Repair System safe for humans?

The Edwards PASCAL Transcatheter Mitral Valve Repair System has been shown to be safe in humans, with studies reporting favorable short and mid-term safety outcomes for patients with mitral valve regurgitation. ^{1 3 6 7 8}

How is the Edwards PASCAL Transcatheter Mitral Valve Repair System treatment different from other treatments for mitral valve regurgitation?

The Edwards PASCAL Transcatheter Mitral Valve Repair System is unique because it uses a minimally invasive approach to repair the mitral valve without open-heart surgery, making it suitable for high-risk patients. It is based on the edge-to-edge repair concept, which allows for precise valve repair even in complex anatomical situations. ^{1 2 3 4 5}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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 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 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]

References

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

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. [2020]

2. England 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. [2018]

3. 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]

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

One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

PASCAL-based mitral valve repair in an all-comer population: acute and mid-term clinical results. [2021]

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

1-Year Outcomes of Transcatheter Edge-to-Edge Repair in Anatomically Complex Degenerative Mitral Regurgitation Patients. [2023]

8. 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]