International Multisite Transcatheter Tricuspid Valve Therapies Registry

Severe Tricuspid Regurgitation Clinical Trial

— TriValve  

Official title:

International Multisite Transcatheter Tricuspid Valve Therapies Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03416166
• Other study ID #: 2016-01753
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2018
• Last updated: January 29, 2018
• Start date: November 1, 2016
• Est. completion date: November 1, 2026

Study information

• Verified date: January 2018
• Source: University of Zurich
• Contact: Maurizio Taramasso, MD, PhD
• Phone: 0041442553728
• Email: maurizio.taramasso[@]usz.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with significant morbidity and mortality. Hence, physicians tend to refer patients more aggressively to surgery (1).

Transcatheter procedures are an attractive alternative in high-risk patients. The field of transcatheter tricuspid devices has rapidly advanced over the last few years (2). Limited knowledge is available regarding the epidemiologic and anatomical settings in which these therapies are preferentially applied.

The main purpose of this registry is the collection of baseline clinical and anatomical data of the patients treated with transcatheter tricuspid valve therapies, and their outcomes, whenever feasible. Apart from more knowledge regarding the current status in this field, the results could also help the establishment of guidelines with respect to the choice of the transcatheter device selected and to understand which therapy can provide the better outcome in the different anatomies. Moreover, this study will provide important information about the epidemiology of severe tricuspid regurgitation, which is at the moment an undertreated disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 269
• Est. completion date: November 1, 2026
• Est. primary completion date: May 15, 2017
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• All the patients undergoing transcatheter tricuspid valve intervention.

General inclusion criteria:

• Minimal age: 18 years

• Patient is able to give written informed consent to the procedure

Exclusion Criteria:

• Patients not fulfilling the indications for transcatheter tricuspid intervention

Related Conditions & MeSH terms

• Severe Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Transcatheter Tricuspid Intervention
Any available transcatheter tricuspid valve intervention

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Death		30 days
Secondary	NYHA Class		30 days, 1 year
Secondary	TR Reduction		30 days, 1 year