Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regu… (NCT04666480) | Clinical Trial Compass
TerminatedNot Applicable
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation
Stopped: Study device refinement in process
United States1 participantsStarted 2021-04-30
Plain-language summary
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe degenerative mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at up to 4 centers in North America.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 years of age or older
✓. Greater than moderate degenerative mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
✓. Patient must present with an STS Score less than 10%
✓. High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
✓. Patient is approved by an independent Patient Eligibility Committee
✓. New York Heart Association (NYHA) Functional Class III or IV
✓. Patient willing to participate in study and provide signed IRB/EC-approved informed consent
✓. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits
Exclusion criteria
What they're measuring
1
Incidence of all-cause mortality
Timeframe: 30-days
2
Incidence of change from baseline to moderate or less mitral regurgitation (Grade 2+ or less) as evaluated by 2D TTE