Hamburg TranscathEteR Mitral Valve REplacement RegiStry

Mitral Valve Disease Clinical Trial

— HERMES  

Official title:

Hamburg Transcatheter Mitral Valve Replacement Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914468
• Other study ID #: HERMES
• Status: Recruiting
• Start date: March 8, 2021
• Est. completion date: December 31, 2030

Study information

• Verified date: June 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Sebastian Ludwig, MD
• Phone: +49-40-7410-0
• Email: se.ludwig[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Mitral valve regurgitation (MR) emerges as the most frequent valvular heart disease in developed coun-tries with prevalence increasing with age. Mitral valve repair is the gold standard therapeutic strategy in primary MR and is recommended in patients with secondary MR who are in need of revascularization. However, in patients with secondary MR mitral valve repair is associated with a higher rate of MR recurrence compared to mitral valve replacement. Nevertheless, elderly patients often are at high or prohibitive surgical risk and up to one half of all patients with severe MR are not referred to surgery. Transcatheter edge-to-edge mitral valve repair (TEER) constitutes a feasible and effective alternative, but eligibility for TEER is limited in some cases due to suboptimal anatomy or risk of mitral stenosis. Moreover, MR reduction is less predictable and, again, MR may reoccur. Transcatheter mitral valve replacement (TMVR) represents a complementary therapeutic approach for patients with severe MR. This novel therapy promises to reduce MR as durable as surgical valve replacement while reducing the procedural risk with an interventional approach.

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 significant mitral valve disease, at high surgical risk with suboptimal anatomy for TEER, who undergo TMVR screening. In particular, long-term durability and function of implanted bioprosteses will be investigated. Additionally, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR (i.e., TMVR, TEER, surgery and medical therapy).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Disease

Locations

Country	Name	City	State
Germany	University Heart and Vascular Center Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Incidence of death from any cause.	6-60 months
Primary	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.	6-60 months
Primary	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.	6-60 months
Primary	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.	6-60 months
Primary	Mitral regurgitation (MR) severity	Mitral regurgitation (MR) severity measured by transthoracic and/or transesophageal echocardiography. Assessment of MR severity according to current recommendations for valvular heart disease.	6-60 months
Secondary	Change in 6-minute-walking-test (6MWT) distance	6MWT will be performed by all participants at baseline and at follow-up visits.	6-60 months
Secondary	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.	6-60 months
Secondary	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.	6-60 months