Mitral Insufficiency, Mitral Regurgitation
Conditions
Brief summary
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.
Detailed description
The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL System and Edwards PASCAL Precision System in improving MR, functional status and quality of life in a post market setting.
Interventions
DEVICEEdwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement 2. Patient is willing and able to attend all follow-up visits and to perform all tests 3. Provision of written informed consent
Exclusion criteria
1. Patients are not eligible per the current Instructions for Use 2. Non-elective or emergency TEER procedure for mitral regurgitation 3. Patients in ICU prior to the index procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with major adverse events (MAE rates) | 30 days | The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days |
| Change in mitral regurgitation severity (scale of 0-4+) by echocardiography | Discharge: defined as discharge or 7 days post-procedure, whichever comes first | 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 |
Countries
Austria, Germany, Greece, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORPhilipp Lurz, Prof.Dr.med.
Johannes Gutenberg University Mainz
Outcome results
None listed