MiCLASP Post Market Clinical Follow-Up (PMCF) Study

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Insufficiency Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Wien/AKH Wien, Vienna, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Device

Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System

Primary outcomes

Number of patients with major adverse events (MAE rates)

Time frame: 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

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

TMTT Clinical Affairs

CONTACT

[email protected]

+1 (949) 250 ext. 2500

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)

Acronym: MiCLASP

Important dates

Study start: 2019
Primary completion: 2025
Study completion: 2031
First posted: Jun 12, 2020
Registry last updated: Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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