German Registry for Transcatheter Tricuspid Valve Interventions

NCT04653428 | Recruiting DMC

• 1 other identifier: D-TRIK
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tricuspid Regurgitation; Tricuspid Valve Insufficiency; Heart Valve

Keywords

Tricuspid regurgiation; Tricuspid valve insufficiency; Interventional treatment; Heart valve diseases

Outcome Measures

Primary Outcomes (1)

• All-cause death and heart failure hospitalisation

  All-cause death and heart failure hospitalisation 1 year after transcatheter tricuspid valve treatment (TTVT)

  1 year

Secondary Outcomes (9)

• All-cause death and heart failure hospitalisation (long-term)

  up to 5 years

• All-cause death and heart failure hospitalisation (short-term)

  30-90 days

• Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT)

  up to 5 years

• Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT)

  up to 5 years

• Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT)

  up to 5 years

Other Outcomes (1)

• Safety outcome after transcatheter tricuspid valve treatment (TTVT)

  At the day of discharge after transcatheter tricuspid valve treatment (TTVT)

Interventions

Interventional treatment of tricuspid regurgitation DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe symptomatic tricuspid regurgitation, who are not eligible for cardiac surgery due to a high risk of mortality.

You may qualify if:

• 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.

You may not qualify if:

• No agreement to participation
• Age \< 18 years

Sponsors & Collaborators

• LMU Klinikum: lead
• Heart and Diabetes Center North Rhine-Westphalia: collaborator
• Heart Center Leipzig - University Hospital: collaborator
• Mainz University: collaborator
• Universitätsklinikum Köln: collaborator
• University Hospital, Essen: collaborator

Study Sites (1)

Klinikum der LMU Muenchen

Munich, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jörg Hausleiter, MD

  Klinikum der LMU Muenchen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörg Hausleiter, MD

CONTACT

+49 89 4400 72361; joerg.hausleiter@med.uni-muenchen.de

Daniel Braun, MD

CONTACT

+4915254848306; daniel.braun@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 4, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 4, 2020

Record last verified: 2020-11

Locations

DE (1)