Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES)

Hamburg Transcatheter Mitral Valve Replacement Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Disease

Detailed 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).

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • University Heart and Vascular Center Hamburg
    • Contact: Daniel Kalbacher, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
TMVR; Patients undergoing Transcatheter Mitral Valce Replacement (TMVR)
TEER; Patients undergoing mitral Transcatheter Edge-to-Edge Repair (TEER) after screening for TMVR
Surgery; Patients undergoing mitral valve surgery (repair or replacement) after screening for TMVR
Medical therapy; Patients undergoing medical therapy after screening for TMVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Incidence of death from any cause.	6-60 months
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2021
• Primary Completion (ANTICIPATED): December 31, 2030
• Study Completion (ANTICIPATED): December 31, 2030

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (ACTUAL): June 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HERMES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No