German Registry for Transcatheter Tricuspid Valve Interventions

Tricuspid Regurgitation Clinical Trial

Official title:

German Registry for Transcatheter Tricuspid Valve Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04653428
• Other study ID #: D-TRIK
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: November 2020
• Source: Klinikum der Universitaet Muenchen
• Contact: Jörg Hausleiter, MD
• Phone: +49 89 4400 72361
• Email: joerg.hausleiter[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Valve
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Interventional treatment of tricuspid regurgitation
Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair

Locations

Country	Name	City	State
Germany	Klinikum der LMU Muenchen	Munich

Sponsors (6)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen	Heart and Diabetes Center North Rhine-Westphalia, Heart Center Leipzig - University Hospital, Mainz University, Universitätsklinikum Köln, University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety outcome after transcatheter tricuspid valve treatment (TTVT)	The saftety outcome contains all complications which occur between the interventional treatment of the tricuspid regurgitation and discharge from the hospital. Data collection includes: mortality with differentiation of cardiac death and non-cardiac death, unplanned cardiac surgery, re-intervention of tricuspid valve, pericardial tamponade, intervention of coronary arteries. Moreover major adverse events as defined by MVARC2 criteria are recorded at discharge from hospital: death with differentiation of cardiac death and non-cardiac death, peri-procedural or spontaneous myocardial infarction, stroke, transient ischemic attack, life-threatening, major or minor bleeding, acute kidney failure, complications of the vascular access.	At the day of discharge after transcatheter tricuspid valve treatment (TTVT)
Primary	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	All-cause death and heart failure hospitalisation (long-term)	Long-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)	up to 5 years
Secondary	All-cause death and heart failure hospitalisation (short-term)	Short-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)	30-90 days
Secondary	Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT)	Assessed by echocardiography, tricuspid regurgitation graded on a 4-grade scale.	up to 5 years
Secondary	Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT)	Assessment for cardiopulmonal symptoms include edema scaling	up to 5 years
Secondary	Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT)	NYHA classification I, II, III or IV	up to 5 years
Secondary	Change of 6-minute walking distance test after transcatheter tricuspid valve treatment (TTVT)	Assessed by standardized protocol testing 6-minute walking distance	up to 5 years
Secondary	Change of quality of life after transcatheter tricuspid valve treatment (TTVT)	Quality of life is assessed by standardized questionnaires including the Minnesota Living with Heart Failure Questionnaire	up to 5 years
Secondary	Change of NT-proBNP after transcatheter tricuspid valve treatment (TTVT)	N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in pg/ml	up to 5 years
Secondary	Procedural success 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	At the day of discharge after transcatheter tricuspid valve treatment (TTVT)