MiCLASP Post Market Clinical Follow-Up (PMCF) Study

Edwards Lifesciences

Status: Enrolling

Conditions: Mitral Insufficiency; Mitral Regurgitation

Treatments: Device: Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System

Study type: Observational

Funder types: Industry

Identifiers

NCT04430075

2018-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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