Registry for patients undergoing transcatheter mitral valve replacement
Hamburg Transcatheter Mitral Valve Replacement Registry
Universitätsklinikum Hamburg-Eppendorf · NCT04914468
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf (other) |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT04914468 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals over 18 years old with clinically relevant mitral valve disease who are undergoing screening for TMVR.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hamburg
- University Heart and Vascular Center Hamburg — Hamburg, Germany (RECRUITING)
Study contacts
- Principal investigator: Sebastian Ludwig, MD — University Heart and Vascular Center Hamburg
- Study coordinator: Sebastian Ludwig, MD
- Email: se.ludwig@uke.de
- Phone: +49-40-7410-0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mitral Valve Disease