MiCLASP Post Market Clinical Follow-Up (PMCF) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation, Mitral Insufficiency. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Germany, Greece, Italy, Netherlands +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)
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.
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
- Device Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System
Primary outcome measures
- Number of patients with major adverse events (MAE rates) [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 26 centers
- Universitäts-Herzzentrum Freiburg Campus Bad Krozingen — Bad Krozingen
- Universität Tuebingen — Tübingen
- Uniklinikum Ulm — Ulm
- Uniklinikum Erlangen — Erlangen
- Medizinische Klinik I- Campus Grosshadern — München
- Immanuel Klinikum Bernau — Bernau bei Berlin
- Universitätsklinikum Giessen UKGM — Giessen
- Universitaeres Herzzentrum Goettingen — Göttingen
- … and 18 more centers
Italy · 3 centers
- IRCCS Ospedale San Raffaele — Milan
- Ospedale del Cuore G. Pasquinucci Massa — Massa
- IRCCS Policlinico San Donato — San Donato Milanese
Netherlands · 2 centers
- St. Antonius Ziekenhuis — Nieuwegein
- Erasmus MC — Rotterdam
Austria · 1 center
- Medizinische Universität Wien/AKH Wien — Vienna
Greece · 1 center
- Hygeia Hospital — Athens
Poland · 1 center
- The Cardinal Stefan Wyszyński, Institute of Cardiology — Warsaw
Spain · 1 center
- Hospital Alvaro Cunqueiro — Vigo
Switzerland · 1 center
- Inselspital Bern — Bern
United Kingdom · 1 center
- Wythenshawe Hospital — Manchester
Identifiers
NCT: NCT04430075 · 2018-08