Clinical trial NCT04653428: German Registry for Transcatheter Tricuspid Valve Interventions
Official title: German Registry for Transcatheter Tricuspid Valve Interventions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Regurgitation
Tricuspid Valve Insufficiency
Heart Valve
Keywords: Tricuspid regurgiation
Tricuspid valve insufficiency
Interventional treatment
Heart valve diseases
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
Collaborators: name: Heart and Diabetes Center North Rhine-Westphalia
name: Heart Center Leipzig - University Hospital
name: Mainz University
name: Universitätsklinikum Köln
name: University Hospital, Essen
First posted: 2020-12-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause death and heart failure hospitalisation
timeFrame: 1 year
Secondary outcomes:
measure: All-cause death and heart failure hospitalisation (long-term)
timeFrame: up to 5 years
measure: All-cause death and heart failure hospitalisation (short-term)
timeFrame: 30-90 days
measure: Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT)
timeFrame: up to 5 years
measure: Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT)
timeFrame: up to 5 years
measure: Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT)
timeFrame: up to 5 years
measure: Change of 6-minute walking distance test after transcatheter tricuspid valve treatment (TTVT)
timeFrame: up to 5 years
measure: Change of quality of life after transcatheter tricuspid valve treatment (TTVT)
timeFrame: up to 5 years
measure: Change of NT-proBNP after transcatheter tricuspid valve treatment (TTVT)
timeFrame: up to 5 years
measure: Procedural success after transcatheter tricuspid valve treatment (TTVT)
timeFrame: At the day of discharge after transcatheter tricuspid valve treatment (TTVT)
Other outcomes:
measure: Safety outcome after transcatheter tricuspid valve treatment (TTVT)
timeFrame: At the day of discharge after transcatheter tricuspid valve treatment (TTVT)
Locations:
city: Munich
country: Germany
facility: Klinikum der LMU Muenchen
Study officials:
affiliation: Klinikum der LMU Muenchen
name: Jörg Hausleiter, MD
role: PRINCIPAL_INVESTIGATOR
References: