Edwards PASCAL System for Mitral Valve Regurgitation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center, Philadelphia, PAMitral Valve Regurgitation+2 MoreEdwards PASCAL System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new transcatheter valve repair system in patients with either degenerative or functional mitral regurgitation who are at high risk for mitral valve surgery.

Eligible Conditions
  • Mitral Valve Regurgitation
  • Mitral Valve Disease
  • Mitral Regurgitation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up

Year 1
Functional Improvement (increase in 6 minute walk test in meters)
Year 2
Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years
Year 2
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years
30 days.
PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).
6 months
PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort.
6 months; 12 months
Rates of various adverse events
Year 5
PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only.

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Abbott Mitraclip System - CLASP IID
1 of 5
Abbott Mitraclip System - CLASP IIF
1 of 5
Edwards PASCAL System - Single-Arm Registry
1 of 5
Edwards PASCAL System - CLASP IIF
1 of 5
Edwards PASCAL System - CLASP IID
1 of 5

Active Control

Experimental Treatment

1247 Total Participants · 5 Treatment Groups

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

Edwards PASCAL System - Single-Arm Registry
Device
Experimental Group · 1 Intervention: Edwards PASCAL System · Intervention Types: Device
Edwards PASCAL System - CLASP IIF
Device
Experimental Group · 1 Intervention: Edwards PASCAL System · Intervention Types: Device
Edwards PASCAL System - CLASP IID
Device
Experimental Group · 1 Intervention: Edwards PASCAL System · Intervention Types: Device
Abbott Mitraclip System - CLASP IID
Device
ActiveComparator Group · 1 Intervention: Abbott Mitraclip System · Intervention Types: Device
Abbott Mitraclip System - CLASP IIF
Device
ActiveComparator Group · 1 Intervention: Abbott Mitraclip System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
167 Previous Clinical Trials
57,019 Total Patients Enrolled
Robert Smith, MDPrincipal InvestigatorThe Heart Hospital Baylor Plano
1 Previous Clinical Trials
30 Total Patients Enrolled
Brian K Whisenant, MDPrincipal InvestigatorIntermountain Medical Center
Scott Lim, MDPrincipal InvestigatorUniversity of Virginia
Linda Gillam, MDPrincipal InvestigatorMorristown Medical Center
Paul Grayburn, MDPrincipal InvestigatorThe Heart Hospital Baylor Plano
1 Previous Clinical Trials
396 Total Patients Enrolled
Ralph Stephan von Bardeleben, MDPrincipal Investigator/ Universitätsmedizin Mainz- Zentrum für Kardiologie
Vinod Thourani, MDPrincipal InvestigatorPiedmont Healthcare
7 Previous Clinical Trials
3,014 Total Patients Enrolled
Jörg Hausleiter, MDPrincipal InvestigatorLMU München, Campus Gorsshadern
2 Previous Clinical Trials
630 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are eligible for either PASCAL or MitraClip, which are types of heart valve repair procedures recommended by your heart team.

Who else is applying?

What state do they live in?
Oklahoma100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Oklahoma Cardiovascular100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%

Frequently Asked Questions

What is the current cohort size of this investigation?

"Affirmative. Data provided on clinicaltrials.gov suggests that the trial, which was initially posted in November 2018, is actively seeking participants to enrol. The study requires 1275 patients from 77 medical sites across the country." - Anonymous Online Contributor

Unverified Answer

In which locations can this research be accessed?

"At present, the study is enrolling participants at 77 various sites, with a few being in San Diego, Weston and Washington. To reduce travel costs whilst involved in this trial it is essential to secure an appointment close by your location." - Anonymous Online Contributor

Unverified Answer

What are the primary objectives of this experiment?

"The primary outcome of this trial, monitored from randomization to heart failure hospitalization or death, will assess the degree to which PASCAL is less inferior than Mitraclip in terms of MR severity reduction as measured by echocardiography. Secondary objectives include rates of various adverse events at 6 and 12 months post-intervention, functional improvement (quality of life) assessed via the Short Form Health Survey (SF-36), and an evaluation of the increase in individuals' six minute walk test scores." - Anonymous Online Contributor

Unverified Answer

Are there any openings for enrollment in this clinical trial?

"Clinicaltrials.gov affirms that this medical study is currently searching for volunteers, having first been posted on November 30th 2018 and last updated on November 3rd 2022." - 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.