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Transcatheter Valve Repair System

Edwards PASCAL System for Tricuspid Regurgitation (CLASP II TR Trial)

Led By Michael J. Mack, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eighteen (18) years of age or older
New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
Screening 3 weeks
Treatment Varies
Follow Up 12 months, 24 months
Awards & highlights

CLASP II TR Trial Summary

This trial will test a new device to treat tricuspid valve regurgitation in patients at high risk for surgery.

Who is the study for?
This trial is for adults with severe tricuspid regurgitation, a heart valve disease causing symptoms or hospitalization despite medical treatment. Candidates must be at intermediate or higher risk for surgery complications as assessed by a Heart Team and willing to follow the study's procedures.Check my eligibility
What is being tested?
The Edwards PASCAL Transcatheter Valve Repair System is being tested against Optimal Medical Therapy in patients with symptomatic severe tricuspid regurgitation who are not good candidates for surgery due to high risk of mortality.See study design
What are the potential side effects?
Potential side effects may include bleeding, infection risks associated with catheter-based procedures, possible damage to the heart or vessels where the device is implanted, irregular heartbeats, and in rare cases stroke or death.

CLASP II TR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am 18 years old or older.
I have moderate to severe heart issues or was hospitalized for heart failure in the last year.

CLASP II TR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score)
Secondary outcome measures
1 Grade Reduction in TR Severity
All Cause Mortality
All-Cause Mortality
+10 more

CLASP II TR Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Single-Arm RegistryExperimental Treatment1 Intervention
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
Group II: Edwards PASCAL System & OMTExperimental Treatment1 Intervention
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Group III: Optimal Medical Therapy (OMT)Active Control1 Intervention
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,520 Total Patients Enrolled
Charles Davidson, MDStudy ChairNorthwestern University
2 Previous Clinical Trials
326 Total Patients Enrolled
Michael J. Mack, MDPrincipal InvestigatorBaylor Scott and White Health

Media Library

Edwards PASCAL System (Transcatheter Valve Repair System) Clinical Trial Eligibility Overview. Trial Name: NCT04097145 — N/A
Tricuspid Regurgitation Research Study Groups: Edwards PASCAL System & OMT, Optimal Medical Therapy (OMT), Single-Arm Registry
Tricuspid Regurgitation Clinical Trial 2023: Edwards PASCAL System Highlights & Side Effects. Trial Name: NCT04097145 — N/A
Edwards PASCAL System (Transcatheter Valve Repair System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04097145 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are clinicians recruiting participants for this research endeavor currently?

"As of the latest update on August 5th 2022, this clinical trial is actively seeking participants. The initial posting date was December 11th 2019."

Answered by AI

What results are expected from this experiment?

"This two-year clinical trial is monitoring a Composite endpoint to assess all-cause mortality, RVAD implantation or heart transplantations, tricuspid valve interventions, hospitalizations due to heart failure and Quality of Life improvements (as measured by KCCQ scores). Additionally, secondary outcomes such as Durable RVAD implantation/heart transplants, Health Status - SF-36 scores and Rates of various adverse events at the 30 day mark will be monitored."

Answered by AI

How many individuals are participating in this medical experiment?

"Affirmative, current information on clinicaltrials.gov demonstrates that this medical trial is actively recruiting patients to be part of the study. This experiment was first posted in December 2019 and has been updated as recently as August 2022. It requires 825 individuals across 58 different sites to participate."

Answered by AI

How many healthcare facilities are currently conducting this research?

"The recruitment of participants is underway at the University of Iowa Hospitals & Clinics, Pinnacle Health Cardiovascular Institute/UPMC Pinnacle, Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania as well as another 58 medical sites."

Answered by AI
~101 spots leftby Dec 2024