Registry for patients undergoing transcatheter mitral valve replacement
Official title: Hamburg Transcatheter Mitral Valve Replacement Registry
Run by Universitätsklinikum Hamburg-Eppendorf · NCT04914468 · Data updated 2026-11-12
This study is tracking patients with serious mitral valve problems who are getting a new type of heart valve through a less invasive procedure to see how well it works and how long it lasts.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 110 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Status | Recruiting |
| Started | March 8, 2021 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | June 4, 2021 |
| Trial ID | NCT04914468 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals over 18 years old with clinically relevant mitral valve disease who are undergoing screening for TMVR.
✕Probably not a fit
Patients who are not proficient in the German language or those unable to cooperate due to physical or psychological conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective cohort registry designed to collect follow-up data on the short- and long-term outcomes of patients with significant mitral valve disease who are screened for transcatheter mitral valve replacement (TMVR). This study focuses on the durability and function of implanted bioprostheses and compares various treatment strategies for patients based on their screening results. It aims to provide valuable insights into the effectiveness of TMVR, particularly for patients at high surgical risk with suboptimal anatomy for other interventions.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of TMVR outcomes, leading to improved treatment strategies for patients with mitral valve disease.
How similar studies have gone: While the approach of TMVR is gaining traction, this registry aims to provide specific insights into its long-term outcomes, making it a novel contribution to existing literature.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation. * Individuals over the age of 18 years. * Patients with clinically relevant mitral valve disease, who undergo screening for TMVR. Exclusion Criteria: * Insufficient knowledge of the German language, to understand study documents and interview without translation * Physical or psychological incapability to cooperate in the investigation
Where it's running
-
University Heart and Vascular Center Hamburg
Hamburg, Germany Recruiting
Study contacts
- Principal investigator: Sebastian Ludwig, MD — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Sebastian Ludwig, MD
- Email: se.ludwig@uke.de
- Phone: +49-40-7410-0
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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MRace Implant: A first look at fixing the mitral valve to reduce regurgitation
This single-arm study tests whether the MRace Implant and Delivery System can safely place a prosthesis to reduce severe mitral regurgitation in high-risk patients who may not be good candidates for open-heart surgery.
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Mitral Valve Calcification Imaging with TrueVue 3D Light Rendering
This study tests how well three-dimensional transesophageal echocardiography with TrueVue transillumination detects mitral valve calcifications compared with CT in adults.
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Tracking progression and consequences of heart valve disease
This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.
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Surgical implantation of a polymer prosthetic mitral or aortic valve
This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.
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Abbott Cephea registry for mitral valve disease
Collects clinical information on adults with symptomatic mitral valve disease to see how correcting the valve with the Cephea system affects outcomes for patients who might be candidates for transcatheter mitral valve replacement.
-
Using the CoolCryo System to treat Atrial Fibrillation during Mitral Valve Surgery
This study is testing whether the CoolCryo system can safely help people with atrial fibrillation feel better during mitral valve surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.