Actively Recruiting
Hamburg Transcatheter Mitral Valve Replacement Registry
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2021-06-04
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Mitral valve disease, particularly mitral valve regurgitation (MR), is a common heart valve condition that becomes more frequent with age. This research aims to collect detailed short- and long-term follow-up information on patients with significant mitral valve disease who are at high surgical risk and undergo screening for transcatheter mitral valve replacement (TMVR). The study focuses on the durability and function of implanted bioprosthetic valves and compares different treatment approaches after TMVR screening, including TMVR, transcatheter edge-to-edge repair (TEER), surgery, and medical therapy. Participants in this prospective clinical registry undergo screening for TMVR. Those who qualify may receive TMVR, while others may undergo TEER, mitral valve surgery (repair or replacement), or receive medical therapy instead. The study follows patients regardless of treatment path to assess outcomes and durability of the procedures or therapies they receive. This approach allows comparison of strategies for managing mitral valve disease in patients with suboptimal anatomy for TEER and high surgical risk. During the study, patients will be monitored for outcomes such as all-cause and cardiovascular mortality, rehospitalization for heart failure, unplanned mitral valve interventions, and severity of mitral regurgitation over 6 to 60 months. Secondary measures include changes in walking ability (6-minute walk test), quality of life, and functional heart class. The study collects ongoing clinical data to understand long-term effects and treatment durability, contributing valuable information for managing mitral valve disease.
CONDITIONS
Brief Title
Hamburg TranscathEteR Mitral Valve REplacement RegiStry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written informed consent according to Good Epidemiological Practice and local laws
- Age 18 years or older
- Patients with clinically relevant mitral valve disease undergoing TMVR screening
You will not qualify if you...
- Insufficient knowledge of German to understand study documents and interviews without translation
- Physical or psychological inability to cooperate in the study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months to 5 years
Participants who undergo routine care for mitral valve disease are observed to collect follow-up information on short- and long-term outcomes after TMVR screening, including those receiving TMVR, TEER, surgery, or medical therapy.
Regular visits as part of routine clinical follow-up
Trial Site Locations
Total: 1 location
1
University Heart and Vascular Center Hamburg
Hamburg, Germany, 20246
Actively Recruiting
Research Team
S
Sebastian Ludwig, 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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