← Back to Search

Transcatheter Valve Repair System

Transcatheter Valve Repair for Tricuspid Regurgitation (CLASP TR EFS Trial)

N/A

Waitlist Available

Led By Susheel K. Kodali, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Severe functional or degenerative TR

The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days, 6 months, 12 months, annual for five years

Awards & highlights

CLASP TR EFS Trial Summary

This trial is testing a new valve repair system to see if it is safe and effective in treating tricuspid valve regurgitation.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, transcatheter valve repair procedures can generally include risks such as bleeding, blood vessel complications, irregular heartbeats, and infection risk at the catheter insertion site.

CLASP TR EFS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe valve issues in my heart.

Select...

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

Select...

My symptoms persist despite taking medication.

CLASP TR EFS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days, 3 months ,6 months, 12 months, annual for five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days, 3 months ,6 months, 12 months, annual for five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 3 months ,6 months, 12 months, annual for five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Freedom from device or procedure-related adverse events

Secondary outcome measures

Health Status - KCCQ

Health Status - SF-36

NYHA Functional Class

+2 more

CLASP TR EFS Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Treatment with the Edwards PASCAL Transcatheter Valve Repair System

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

180 Previous Clinical Trials

61,509 Total Patients Enrolled

Susheel K. Kodali, MDPrincipal InvestigatorColumbia University

Media Library

Edwards PASCAL Transcatheter Valve Repair System (Transcatheter Valve Repair System) Clinical Trial Eligibility Overview. Trial Name: NCT03745313 — N/A

Tricuspid Regurgitation Research Study Groups: Treatment

Tricuspid Regurgitation Clinical Trial 2023: Edwards PASCAL Transcatheter Valve Repair System Highlights & Side Effects. Trial Name: NCT03745313 — N/A

Edwards PASCAL Transcatheter Valve Repair System (Transcatheter Valve Repair System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03745313 — N/A

Frequently Asked Questions

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

What is the scope of this trial's implementation in clinical settings?

"Patients can join this research endeavor at University of Virginia Health System in Charlottesville, NYU Langone Health in New york, The Heart Hospital Baylor Plano in Plano and additional 15 sites."

Answered by AI

Does this study have any available vacancies for participants?

"Clinicaltrials.gov reports that this trial is not currently recruiting patients, however it was initially posted on February 5th 2019 and last updated on May 10th 2022. While there are no open recruitment opportunities for this specific study right now, 40 other studies connected to this field are actively searching for participants."

Answered by AI

Recent research and studies

Journal of the American College of CardiologyJournal

Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation

Kodali, Susheel, Rebecca T. Hahn, Mackram F. Eleid, Robert Kipperman, Robert Smith, D. Scott Lim, William A. Gray, et al.. 2021. “Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2020.11.047.

clinicaltrials.govStudy

Edwards CLASP TR EFS

2019. "Edwards CLASP TR EFS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03745313.

All > Tricuspid Regurgitation