The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with mitral valve disease that undergo transcatheter mitral valve replacement (TMVR) screening. In particular, long-term durability and function of implanted bioprosteses is of utmost interest for both patients and clinicians. Moreover, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR.
Eligibility
Sex
ALL
Min age
18 Years
Max age
110 Years
Healthy volunteers
No
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
Primary outcome measure(s)
All-cause mortality — 6-60 months Incidence of death from any cause.
Cardiovascular mortality — 6-60 months Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.
Rehospitalization for congestive heart failure — 6-60 months Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews.
Unplanned mitral valve intervention — 6-60 months Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or assist device implantation, e.g. as assessed by patient interviews.
Mitral regurgitation (MR) severity — 6-60 months Mitral regurgitation (MR) severity measured by transthoracic and/or transesophageal echocardiography. Assessment of MR severity according to current recommendations for valvular heart disease.
Trial sites (1)
Facility
City
Region
Status
University Heart and Vascular Center Hamburg
Hamburg
Germany
Recruiting
More Universitätsklinikum Hamburg-Eppendorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.