German Registry for Transcatheter Tricuspid Valve Interventions

Recruiting

• Conditions: Tricuspid Regurgitation; Tricuspid Valve Insufficiency; Heart Valve

• Registration Number: NCT04653428
• Lead Sponsor: LMU Klinikum

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-28
• Last Update Submitted: 2020-11-28
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change of 6-minute walking distance test after transcatheter tricuspid valve treatment (TTVT)	up to 5 years	Assessed by standardized protocol testing 6-minute walking distance
Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT)	up to 5 years	NYHA classification I, II, III or IV
Change of NT-proBNP after transcatheter tricuspid valve treatment (TTVT)	up to 5 years	N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in pg/ml
Procedural success after transcatheter tricuspid valve treatment (TTVT)	At the day of discharge after transcatheter tricuspid valve treatment (TTVT)	Procedural success is defined as a reduction of the tricuspid regurgitation to at least grade 2+ achieved by interventional treatment
All-cause death and heart failure hospitalisation (long-term)	up to 5 years	Long-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)
Change of quality of life after transcatheter tricuspid valve treatment (TTVT)	up to 5 years	Quality of life is assessed by standardized questionnaires including the Minnesota Living with Heart Failure Questionnaire
All-cause death and heart failure hospitalisation (short-term)	30-90 days	Short-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)
Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT)	up to 5 years	Assessment for cardiopulmonal symptoms include edema scaling
Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT)	up to 5 years	Assessed by echocardiography, tricuspid regurgitation graded on a 4-grade scale.

Trial Locations

Locations (1)

Klinikum der LMU Muenchen; 🇩🇪 Munich, Germany