Edwards PASCAL System for Tricuspid Regurgitation

Phase-Based Progress Estimates
TriHealth-Bethesda North Hospital, Cincinnati, OHTricuspid Regurgitation+2 MoreEdwards PASCAL System - Device
All Sexes
What conditions do you have?

Study Summary

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

Eligible Conditions
  • Tricuspid Regurgitation
  • Tricuspid Valve Disease

Treatment Effectiveness

Study Objectives

2 Primary · 17 Secondary · Reporting Duration: 12 months, 24 months

12 months
1 Grade Reduction in TR Severity
All-cause Hospitalization
Death and Heart Failure Hospitalizations
Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Right ventricular end-diastolic volume (RVEDV)
12 months, 24 months
All Cause Mortality
Year 5
All-Cause Mortality
Heart Transplantation
Heart failure hospitalizations
Need for paracentesis
Non-elective tricuspid valve re-intervenitions (percutaneous or surgical)
24 months
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)
Hierarchical composite endpoint of various adverse events and improvement in quality of life
30 days
Major Adverse Events (MAEs)
Rates of various adverse events
Year 2
Health Status - KCCQ
Health Status - SF-36
Six-Minute Walk Test
Intraprocedural post-implantation
Reduction in TR grade

Trial Safety

Trial Design

3 Treatment Groups

Optimal Medical Therapy (OMT)
1 of 3
Edwards PASCAL System & OMT
1 of 3
Single-Arm Registry
1 of 3

Active Control

Experimental Treatment

825 Total Participants · 3 Treatment Groups

Primary Treatment: Edwards PASCAL System · No Placebo Group · N/A

Edwards PASCAL System & OMT
Experimental Group · 1 Intervention: Edwards PASCAL System · Intervention Types: Device
Single-Arm Registry
Experimental Group · 1 Intervention: Edwards PASCAL System · Intervention Types: Device
Optimal Medical Therapy (OMT)
ActiveComparator Group · 1 Intervention: Optimal Medical Therapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months, 24 months

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
167 Previous Clinical Trials
57,441 Total Patients Enrolled
Charles Davidson, MDPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
336 Total Patients Enrolled
Michael J. Mack, MDPrincipal InvestigatorBaylor Scott and White Health
Allen Anderson, MDStudy ChairUT Health San Antonio
3 Previous Clinical Trials
659 Total Patients Enrolled
Martin B. Leon, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
1,338 Total Patients Enrolled
Gorav Ailawadi, MDStudy ChairUniversity of Michigan
2 Previous Clinical Trials
1,458 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Even with medical treatment, your heart team has determined that you have signs or symptoms of TR, or have been hospitalized in the past due to TR-related heart failure.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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 [transplant](https://www.withpower.com/clinical-trials/transplant)ations, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.