Hamburg TranscathEteR Mitral Valve REplacement RegiStry
ConditionMitral Valve Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorUniversitätsklinikum Hamburg-Eppendorf
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Insufficient knowledge of the German language, to understand study documents and interview without translation
Physical or psychological incapability to cooperate in the investigation
Trial population
All patients with clinically significant mitral valve regurgitation that undergo screening for Transcatheter Mitral Valve Replacement (TMVR) at University Heart and Vascular Center Hamburg shall be included. This includes inpatients and outpatients of the University Heart and Vascular Center Hamburg and may be extended to patients from other national or foreign centers. Inclusion into the study will take place after written informed consent is obtained. Patients included in interventional device studies (e.g., early feasibility TMVR studies, post-market TMVR studies etc.) may also be included in HERMES.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 4 trial groupsGroup A: TMVR
Group B: TEER
Group C: Surgery
Group D: Medical therapy
Trial outcomes
Primary outcomes
1
All-cause mortality
Incidence of death from any cause.
Time frame
6-60 months2
Cardiovascular mortality
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.
Time frame
6-60 months3
Rehospitalization for congestive heart failure
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.
Time frame
6-60 months4
Unplanned mitral valve intervention
Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or assist device implantation, e.g. as assessed by patient interviews.
Time frame
6-60 monthsSecondary outcomes
1
Change in 6-minute-walking-test (6MWT) distance
6MWT will be performed by all participants at baseline and at follow-up visits.
Time frame
6-60 months2
Change in quality of life
Quality of life will be assessed by a standardized questionnaire \[Kansas City Cardiomyopathy Questionnaire \[KCCQ\]) in all participants at baseline and at follow-up visits (or by phone interviews). The score is represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and a score of 100 indicates no symptoms, no limitations, and excellent quality of life.
Time frame
6-60 months3
Change in New York Heart Association (NYHA) functional class
New York Heart Association \[NYHA\] functional class (I-IV) will be assessed in all participants at baseline and at follow-up visits (or by phone interviews). NYHA Class I: No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. NYHA Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. NYHA Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest. NYHA Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Time frame
6-60 monthsSponsors and contacts
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Source ClinicalTrials.gov