Clinical trial NCT04430075: MiCLASP Post Market Clinical Follow-Up (PMCF) Study
Official title: Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Regurgitation
Mitral Insufficiency
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2020-06-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient mitral valve \[MR ≥ 2+ (PASCAL patients) or MR ≥ 3+ (PASCAL Precision patients)\] by a Heart Team who assesses patient risk and anatomic suitability should be considered for inclusion in this trial.

Brief summary: 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.

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

Primary outcomes:
measure: Number of patients with major adverse events (MAE rates)
timeFrame: 30 days
measure: Change in mitral regurgitation severity (scale of 0-4+) by echocardiography
timeFrame: Discharge: defined as discharge or 7 days post-procedure, whichever comes first
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Medizinische Universität Wien/AKH Wien
city: Tübingen
country: Germany
facility: Universität Tuebingen
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Uniklinikum Ulm
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: Uniklinikum Erlangen
state: Bavaria
city: München
country: Germany
facility: Medizinische Klinik I- Campus Grosshadern
state: Bavaria
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau
state: Brandenburg
city: Gießen
country: Germany
facility: Universitätsklinikum Giessen UKGM
state: Hessen
city: Göttingen
country: Germany
facility: Universitaeres Herzzentrum Goettingen
state: Lower Saxony
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum / Uniklinik Essen
state: Nordrhine Westfalia
city: Essen
country: Germany
facility: Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen
state: Nordrhine Westfalia
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Bad Oeynhausen
state: North Rhine-Westphalia
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: North Rhine-Westphalia
city: Cologne
country: Germany
facility: Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne
state: North Rhine-Westphalia
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital
state: North Rhine-Westphalia
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz
state: North Rhine-Westphalia
city: Siegburg
country: Germany
facility: Helios Klinikum Siegburg
state: North Rhine-Westphalia
city: Dresden
country: Germany
facility: Herzzentrum Universitätsklinik Dresden
state: Saxonia
city: Lübeck
country: Germany
facility: Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Berlin
country: Germany
facility: Charité Berlin
city: Berlin
country: Germany
facility: Charité Berlin
city: Frankfurt
country: Germany
facility: MVZ-CCB
city: Hamburg
country: Germany
facility: Universitares Herzzentrum Hamburg
city: Hamburg
country: Germany
facility: Kath. Marienkrankenhaus Hamburg GmbH
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Leipzig
country: Germany
facility: Heart Centre of the University Leipzig
city: Athens
country: Greece
facility: Hygeia Hospital
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardy
city: Massa
country: Italy
facility: Ospedale del Cuore G. Pasquinucci Massa
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Warsaw
country: Poland
facility: The Cardinal Stefan Wyszyński, Institute of Cardiology
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Philipp Lurz, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: