MiCLASP Post Market Clinical Follow-Up (PMCF) Study

N/AActive Not RecruitingNCT04430075

Edwards Lifesciences1,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Mitral Regurgitation Mitral Insufficiency

Interventions

Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair SystemDEVICE

Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (37)

Outcomes

Primary Outcomes

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 days

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 first

Data from ClinicalTrials.gov

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Medizinische Universität Wien/AKH Wien

Vienna, Austria

Universitäts-Herzzentrum Freiburg Campus Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, Germany

Universität Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Uniklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Uniklinikum Erlangen

Erlangen, Bavaria, Germany

Medizinische Klinik I- Campus Grosshadern

München, Bavaria, Germany

Immanuel Klinikum Bernau

Bernau bei Berlin, Brandenburg, Germany

Universitätsklinikum Giessen UKGM

Giessen, Hesse, Germany

Universitaeres Herzzentrum Goettingen

Göttingen, Lower Saxony, Germany

Westdeutsches Herzzentrum / Uniklinik Essen

Essen, Nordrhine Westfalia, Germany

...and 27 more locations