Edwards PASCAL System for Mitral Valve Regurgitation
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.
- Mitral Valve Regurgitation
- Mitral Valve Disease
- Mitral Regurgitation
Treatment Effectiveness
Effectiveness Progress
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
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Oklahoma | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Oklahoma Cardiovascular | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
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
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
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
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