NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

MiCLASP Post Market Clinical Follow-Up (PMCF) Study

Active Not RecruitingN/A

Sponsor: Edwards Lifesciences

Conditions: Mitral Regurgitation, Mitral Insufficiency

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

Countries: Austria, Germany, Greece, Italy, Netherlands, Poland, Spain, Switzerland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

Vienna, Austria
Bad Krozingen, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
Ulm, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
München, Bavaria, Germany
Bernau bei Berlin, Brandenburg, Germany
Giessen, Hesse, Germany
Göttingen, Lower Saxony, Germany
Essen, Nordrhine Westfalia, Germany
Essen, Nordrhine Westfalia, Germany
Bad Oeynhausen, North Rhine-Westphalia, Germany
Bonn, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Dortmund, North Rhine-Westphalia, Germany
Mainz, North Rhine-Westphalia, Germany
Siegburg, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Lübeck, Schleswig-Holstein, Germany
Bad Berka, Germany
Berlin, Germany
Berlin, Germany
Frankfurt, Germany
Hamburg, Germany
Hamburg, Germany
Kiel, Germany
Leipzig, Germany
Athens, Greece
Milan, Lombardy, Italy
Massa, Italy
+ 7 more on CT.gov