Phenotypic clustering analysis of patients rejected for mitral valve interventions: implications for future transcatheter technologies.
Sebastian Ludwig, Augustin Coisne, Kenza Hamzi...
https://pubmed.ncbi.nlm.nih.gov/40329826Actively Recruiting
Age: 18Years +
All Genders
ID04688190
Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2026-05-07
1000
Participants Needed
43
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
Universitätsklinikum Hamburg-Eppendorf
Lead Sponsor
M
Montreal Heart Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying clinical outcomes in patients undergoing transcatheter mitral valve replacement (TMVR) for mitral insufficiency. This multinational registry focuses on patients treated with TMVR in real-world practice and collects data on those who have undergone screening for TMVR. Some historical data include patients who received other treatments like edge-to-edge repair, mitral valve surgery, or medical therapy. The registry includes patients who successfully underwent TMVR with any device. Patients who failed TMVR screening and underwent other treatments such as mitral valve edge-to-edge repair, mitral valve surgery, or medical therapy were previously included but are no longer systematically enrolled. The study collects data over various timepoints to observe the effects of these therapies. Participants are followed for at least 30 days after treatment with echocardiography and clinical evaluations. Researchers measure mitral insufficiency severity, device-related complications within 30 days, and longer-term outcomes like mortality, rehospitalization for heart failure, and unplanned mitral valve interventions over 12 months. This observational registry aims to understand outcomes and safety in patients treated with TMVR and related therapies in routine care.
CONDITIONS
Brief Title
CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Clinically significant mitral insufficiency
- Patient underwent screening for transcatheter mitral valve implantation (TMVI)
- Echocardiography data available at baseline and after TMVI, edge-to-edge repair, or surgery
- Follow-up of at least 30 days
You will not qualify if you...
- Age under 18 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - At least 30 days up to 12 months
Participants who undergo routine care for mitral insufficiency, including transcatheter mitral valve replacement, edge-to-edge repair, surgery, or medical therapy, are observed for outcomes.
Follow-up visits at baseline and after treatment up to 12 months
Trial Site Locations
Total: 43 locations
1
Tucson Medical Center
Tucson, Arizona, United States, 85712
Actively Recruiting
2
Cedars-Sinai Medical Center, Los Angeles
Los Angeles, California, United States, 90048
Actively Recruiting
3
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
6
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
7
Montefiore Medical Center
New York, New York, United States, 10461
Actively Recruiting
8
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
9
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
10
St Vincent's Hospital
Sydney, Australia
Actively Recruiting
11
Medical University of Vienna
Vienna, Austria
Actively Recruiting
12
Québec Heart and Lung Institute (Laval University)
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
13
Toronto Heart Center
Toronto, Canada
Actively Recruiting
14
St. Paul's Hospital
Vancouver, Canada
Actively Recruiting
15
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
16
CHU Bordeaux
Bourdeaux, France
Actively Recruiting
17
Lille University Hospital
Lille, France
Actively Recruiting
18
Civils Hospices of Lyon
Lyon, France
Actively Recruiting
19
Clinique Pasteur
Toulouse, France
Actively Recruiting
20
HDZ Bad Oeynhausen
Bad Oeynhausen, Germany
Actively Recruiting
21
German Heart Center Berlin
Berlin, Germany
Actively Recruiting
22
Heart Center Bonn
Bonn, Germany
Actively Recruiting
23
University Hospital of Cologne
Cologne, Germany
Actively Recruiting
24
Goethe-Universität - University Hospital Frankfurt
Frankfurt, Germany
Actively Recruiting
25
University Heart and Vascular Center Hamburg
Hamburg, Germany
Actively Recruiting
26
University Heart Center Lübeck
Lübeck, Germany
Actively Recruiting
27
Heart Center of the University Medical Center Mainz
Mainz, Germany
Actively Recruiting
28
German Heart Centre Munich
Munich, Germany
Actively Recruiting
29
LMU Munich
Munich, Germany
Actively Recruiting
30
University Medical Center Ulm
Ulm, Germany
Actively Recruiting
31
Interbalkan Medical Center
Thessaloniki, Greece
Actively Recruiting
32
ASST Spedali Civili di Brescia
Brescia, Italy
Actively Recruiting
33
San Raffaele University Hospital
Milan, Italy
Actively Recruiting
34
IRCCS Humanitas Research Hospital
Milan, Italy, 20089
Actively Recruiting
35
IRCCS Policlinico San Donato
Milan, Italy
Actively Recruiting
36
University Hospital of Pisa
Pisa, Italy
Actively Recruiting
37
Rikshospitalet, Oslo University Hospital (OUS)
Oslo, Norway
Actively Recruiting
38
Poznan University of Medical Sciences
Poznan, Poland
Actively Recruiting
39
Warsaw Medicover Hospital
Warsaw, Poland
Actively Recruiting
40
Inselspital Bern
Bern, Switzerland
Actively Recruiting
41
USZ Zurich
Zurich, Switzerland
Actively Recruiting
42
Royal Brompton Hospital
London, United Kingdom
Actively Recruiting
43
St Thomas' Hospital - London
London, United Kingdom
Actively Recruiting
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Research Team
S
Sebastian Ludwig, MD
L
Lena Strotmann, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Published Research Related To This Trial
Outcomes Following Transcatheter Mitral Valve Replacement Using Dedicated Devices in Patients With Mitral Annular Calcification.
Augustin Coisne, Sebastian Ludwig, Andrea Scotti...
https://pubmed.ncbi.nlm.nih.gov/39243262Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison.
Sebastian Ludwig, Lenard Conradi, David J Cohen...
https://pubmed.ncbi.nlm.nih.gov/37194288