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Clinical Trials/NCT03416166
NCT03416166
Recruiting
Not Applicable

International Multisite Transcatheter Tricuspid Valve Therapies Registry

University of Zurich1 site in 1 country269 target enrollmentNovember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Tricuspid Regurgitation
Sponsor
University of Zurich
Enrollment
269
Locations
1
Primary Endpoint
Cardiovascular Death
Status
Recruiting
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2016
End Date
November 1, 2026
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cardiovascular Death

Time Frame: 30 days

Secondary Outcomes

  • TR Reduction(30 days, 1 year)
  • NYHA Class(30 days, 1 year)

Study Sites (1)

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