Hamburg TranscathEteR Mitral Valve REplacement RegiStry

NCT04914468 | Recruiting

• 1 other identifier: HERMES
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Valve Disease

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Change in 6-minute-walking-test (6MWT) distance

  6-60 months

• Change in quality of life

  6-60 months

• Change in New York Heart Association (NYHA) functional class

  6-60 months

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Insufficient knowledge of the German language, to understand study documents and interview without translation
• Physical or psychological incapability to cooperate in the investigation

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Heart and Vascular Center Hamburg

Hamburg, 20246, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Standardized methods for sample collection, processing, and storage, as well as appropriate storage facilities, are established and managed in accordance with the highest scientific and ethical standards. To ensure uniformity, quality, and reproducibility for the collection, processing, and storage of biomaterial, standard operating procedures (SOPs) are implemented. The following biomaterial will be sampled for additional biobanking within study visits: * Blood (whole blood, serum, plasma (EDTA, citrated,), DNA, RNA, washed erythrocytes * Urine * Tissue/ cells

Study Officials

• Sebastian Ludwig, MD

  University Heart and Vascular Center Hamburg

  PRINCIPAL INVESTIGATOR

• Edith Lubos, MD

  University Heart and Vascular Center Hamburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Ludwig, MD

CONTACT

+49-40-7410-0; se.ludwig@uke.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 4, 2021
• Study Start: March 8, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)