Clinical trial NCT04688190: CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry
Official title: Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Regurgitation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Montreal Heart Institute
name: University Hospital, Bordeaux
First posted: 2020-12-29
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aimes to include all patients with significant mitral insufficiency, who underwent screening for possible transcatheter mitral valve implantation (TMVI), irrespective of the subsequent therapy.

Brief summary: This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.


Eligibility criteria: Inclusion Criteria:

* clinically significant mitral insufficiency
* patient underwent screening for TMVI
* echocardiography data at baseline (and after TMVI, E2E and surgery)
* follow-up of at least 30 days

Exclusion Criteria:

- age under 18 years

Primary outcomes:
measure: Mitral insufficiency grade 2+ or more
timeFrame: 12 months
measure: Freedom from device-related complications
timeFrame: 30 days
Secondary outcomes:
measure: Combined all-cause mortality or rehospitalization for congestive heart failure
timeFrame: 12 months
measure: All-cause mortality
timeFrame: 12 months
measure: Cardiovascular mortality
timeFrame: 12 months
measure: Rehospitalization for congestive heart failure
timeFrame: 12 months
measure: Combined cardiovascular mortality or rehospitalization for congestive heart failure
timeFrame: 12 months
measure: Unplanned mitral valve intervention
timeFrame: 12 months
measure: Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention
timeFrame: 12 months
measure: Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention
timeFrame: 12 months
measure: New York Heart Association (NYHA) stage III or IV
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Los Angeles
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Sydney
country: Australia
facility: St Vincent's Hospital
city: Toronto
country: Canada
facility: Toronto Heart Center
city: Vancouver
country: Canada
facility: St. Paul's Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Bourdeaux
country: France
facility: CHU Bordeaux
city: Lille
country: France
facility: Lille University Hospital
city: Lyon
country: France
facility: Civils Hospices of Lyon
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Oeynhausen
country: Germany
facility: HDZ Bad Oeynhausen
city: Berlin
country: Germany
facility: German Heart Center Berlin
city: Bonn
country: Germany
facility: Heart Center Bonn
city: Cologne
country: Germany
facility: University Hospital of Cologne
city: Frankfurt
country: Germany
facility: Goethe-Universität - University Hospital Frankfurt
city: Hamburg
country: Germany
facility: University Heart and Vascular Center Hamburg
city: Mainz
country: Germany
facility: Heart Center of the University Medical Center Mainz
city: Munich
country: Germany
facility: German Heart Centre Munich
city: Munich
country: Germany
facility: LMU Munich
city: Milan
country: Italy
facility: San Raffaele University Hospital
city: Oslo
country: Norway
facility: Rikshospitalet, Oslo University Hospital (OUS)
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Zürich
country: Switzerland
facility: USZ Zurich
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: St Thomas' Hospital - London
Study officials:
affiliation: University Heart and Vascular Center Hamburg
name: Lenard Conradi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Thomas Modine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heart and Vascular Center Hamburg
name: Sebastian Ludwig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montreal Heart Institute
name: Walid Ben Ali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton Hospital, London
name: Alison Duncan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Medical Center, NYC
name: Gilbert Tang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Research Foundation, New York, USA
name: Juan F Granada, MD
role: PRINCIPAL_INVESTIGATOR
References: