International Multisite Transcatheter Tricuspid Valve Therapies Registry

Recruiting

• Conditions: Severe Tricuspid Regurgitation

• Registration Number: NCT03416166
• Lead Sponsor: University of Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2017-05-15
• Status Verified: 2018-01
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-29
• Last Update Submitted: 2018-01-29
• Study First Posted: 2018-01-30
• Last Update Posted: 2018-01-30
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 269

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular Death	30 days

Secondary Outcome Measures

Name	Time	Method
TR Reduction	30 days, 1 year
NYHA Class	30 days, 1 year

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Switzerland