Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04688190




Registration number
NCT04688190
Ethics application status
Date submitted
18/12/2020
Date registered
29/12/2020
Date last updated
17/05/2022

Titles & IDs
Public title
CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry
Scientific title
Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry
Secondary ID [1] 0 0
CHOICE-MI
Universal Trial Number (UTN)
Trial acronym
CHOICE-MI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Transcatheter Mitral Valve Implantation (TMVI) - Patients with successful TMVI screening, who underwent Transcatheter Mitral Valve Implantation subsequently. All devices may be included.

Interventional mitral valve edge-to-edge repair (E2E) - Patients with TMVI screening failure, who subsequently underwent interventional mitral valve edge-to-edge repair.

Mitral valve surgery (Surgery) - Patients with TMVI screening failure, who subsequently underwent mitral valve surgery (i.e., mitral valve repair or replacement).

Medical therapy (OMT) - Patients with TMVI screening failure, who subsequently underwent conservative or optimal medical therapy (OMT).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mitral insufficiency grade 2+ or more
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Freedom from device-related complications
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Combined all-cause mortality or rehospitalization for congestive heart failure
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
All-cause mortality
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Cardiovascular mortality
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Rehospitalization for congestive heart failure
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Combined cardiovascular mortality or rehospitalization for congestive heart failure
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Unplanned mitral valve intervention
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
New York Heart Association (NYHA) stage III or IV
Timepoint [9] 0 0
12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- age under 18 years

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Canada
State/province [4] 0 0
Toronto
Country [5] 0 0
Canada
State/province [5] 0 0
Vancouver
Country [6] 0 0
Denmark
State/province [6] 0 0
Copenhagen
Country [7] 0 0
France
State/province [7] 0 0
Bourdeaux
Country [8] 0 0
France
State/province [8] 0 0
Lille
Country [9] 0 0
France
State/province [9] 0 0
Lyon
Country [10] 0 0
France
State/province [10] 0 0
Toulouse
Country [11] 0 0
Germany
State/province [11] 0 0
Bad Oeynhausen
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Germany
State/province [13] 0 0
Bonn
Country [14] 0 0
Germany
State/province [14] 0 0
Cologne
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Germany
State/province [17] 0 0
Mainz
Country [18] 0 0
Germany
State/province [18] 0 0
Munich
Country [19] 0 0
Italy
State/province [19] 0 0
Milan
Country [20] 0 0
Norway
State/province [20] 0 0
Oslo
Country [21] 0 0
Switzerland
State/province [21] 0 0
Bern
Country [22] 0 0
Switzerland
State/province [22] 0 0
Zürich
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Universitätsklinikum Hamburg-Eppendorf
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Montreal Heart Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University Hospital, Bordeaux
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04688190
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lenard Conradi, MD
Address 0 0
University Heart and Vascular Center Hamburg
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sebastian Ludwig, MD
Address 0 0
Country 0 0
Phone 0 0
+4915222816168
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04688190