German Registry for Transcatheter Tricuspid Valve Interventions

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

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Valve Insufficiency; Tricuspid Regurgitation; Heart Valve
• Intervention / Treatment: Device: Interventional treatment of tricuspid regurgitation

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 Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Jörg Hausleiter, MD; Phone Number: +49 89 4400 72361; Email: joerg.hausleiter@med.uni-muenchen.de
• Study Contact Backup: Name: Daniel Braun, MD; Phone Number: +4915254848306; Email: daniel.braun@med.uni-muenchen.de

Study Locations

• Germany
  • Munich, Germany
    • Recruiting
    • Klinikum der LMU Muenchen
    • Contact: Jörg Hausleiter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT)	Assessment for cardiopulmonal symptoms include edema scaling	up to 5 years
Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT)	NYHA classification I, II, III or IV	up to 5 years
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
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
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
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Collaborators: University Hospital, Essen; Heart Center Leipzig - University Hospital; Universitätsklinikum Köln; Heart and Diabetes Center North Rhine-Westphalia; Mainz University
• Investigators: Principal Investigator: Jörg Hausleiter, MD, Klinikum der LMU Muenchen

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2025
• Study Completion (ANTICIPATED): December 31, 2030

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 28, 2020
• First Posted (ACTUAL): December 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2020
• Last Update Submitted That Met QC Criteria: November 28, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Heart valve diseases; Tricuspid regurgiation; Tricuspid valve insufficiency; Interventional treatment
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: D-TRIK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No