MedDataX Logo

German Registry for Transcatheter Tricuspid Valve Interventions

NCT ID: NCT04653428

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Severe tricuspid regurgitation occurs in around 1.5 % of men and 5.6 % of women and it is associated with significant morbidity and mortality. Current guidelines recommend cardiac surgery, especially in those patients who are undergoing left side valve surgery. Nevertheless many patients are not eligible for surgical tricuspid valve repair due to an high risk of mortality. Therefore interventional devices for treatment of tricuspid regurgitation have been established to offer these patients an alternative treatment option. The aim of this study is to analyse the success and saftey aspects of different interventional repair techniques for severe tricuspid regurgitation. Therefore in this prospectively designed observational study clinical, echocardiographic and laboratory parameters will be collected.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tricuspid Regurgitation Tricuspid Valve Insufficiency Heart Valve

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Tricuspid regurgiation Tricuspid valve insufficiency Interventional treatment Heart valve diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interventional treatment of tricuspid regurgitation

Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair
* Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission.

Exclusion Criteria

* No agreement to participation
* Age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heart and Diabetes Center North Rhine-Westphalia

OTHER

Sponsor Role collaborator

Heart Center Leipzig - University Hospital

OTHER

Sponsor Role collaborator

Mainz University

OTHER

Sponsor Role collaborator

Universitätsklinikum Köln

OTHER

Sponsor Role collaborator

University Hospital, Essen

OTHER

Sponsor Role collaborator

LMU Klinikum

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. med. Jörg Hausleiter

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jörg Hausleiter, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der LMU Muenchen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klinikum der LMU Muenchen

Munich, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jörg Hausleiter, MD

Role: CONTACT

Phone: +49 89 4400 72361

Email: [email protected]

Daniel Braun, MD

Role: CONTACT

Phone: +4915254848306

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jörg Hausleiter

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D-TRIK

Identifier Type: -

Identifier Source: org_study_id