Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04688190