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NCT Number: NCT04914468

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.

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Key information

Conditions

Mitral Valve Disease

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Heart and Vascular Center Hamburg

Hamburg, 20246, Germany

Location status: Recruiting

Location contact

Daniel Kalbacher, MD

CONTACT

Edith Lubos, MD

PRINCIPAL_INVESTIGATOR

Sebastian Ludwig, MD

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 6-60 months

    Incidence of death from any cause.

  2. Cardiovascular mortality

    Time frame: 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.

  3. Rehospitalization for congestive heart failure

    Time frame: 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.

  4. Unplanned mitral valve intervention

    Time frame: 6-60 months

    Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or assist device implantation, e.g. as assessed by patient interviews.

  5. Mitral regurgitation (MR) severity

    Time frame: 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.

Secondary outcomes

  1. Change in 6-minute-walking-test (6MWT) distance

    Time frame: 6-60 months

    6MWT will be performed by all participants at baseline and at follow-up visits.

  2. Change in quality of life

    Time frame: 6-60 months

    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.

  3. Change in New York Heart Association (NYHA) functional class

    Time frame: 6-60 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastian Ludwig, MD

CONTACT

[email protected]

+49-40-7410-0

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Acronym: HERMES

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Jun 4, 2021
Registry last updated
Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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