MiCLASP Post Market Clinical Follow-Up (PMCF) Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEdwards Lifesciences
About this trial
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
Patient is willing and able to attend all follow-up visits and to perform all tests
Provision of written informed consent
Disqualifiers
Patients are not eligible per the current Instructions for Use
Non-elective or emergency TEER procedure for mitral regurgitation
Patients in ICU prior to the index procedure
Trial population
Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient mitral valve \[MR ≥ 2+ (PASCAL patients) or MR ≥ 3+ (PASCAL Precision patients)\] by a Heart Team who assesses patient risk and anatomic suitability should be considered for inclusion in this trial.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
DeviceTranscatheter Valve Repair with Edwards PASCAL and PASCAL Precision System
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Number of patients with major adverse events (MAE rates)
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
Time frame
30 days2
Change in mitral regurgitation severity (scale of 0-4+) by echocardiography
Mitral regurgitation severity will be assessed by echocardiography at timepoint discharge on a scale from 0-4+ and compared to timepoint baseline Mitral regurgitation severity
Time frame
Discharge: defined as discharge or 7 days post-procedure, whichever comes firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov