Clinical Trials Study

N/A

International Multisite Transcatheter Tricuspid Valve Therapies Registry

Conditions: Severe Tricuspid Regurgitation

Study #:
NCT03416166
Last Updated:
01/30/2018
Recruitment Status:
Recruiting
Estimated Study Completion Date:
11/01/2026

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.

Age: 18 Years to 99 Years old

Gender: All

Start Date: 11/01/2016

Primary Completion Date (Estimated): 05/15/2017

Study Completion Date (Estimated): 11/01/2026

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years to 99 Years old

Gender: All

Accepts Healthy Volunteers: No

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

Principal Investigator

Mohamed Azeem Latib, MD

For more information about this study, contact:

Mohamed Azeem Latib

646-773-2076

mlatib@montefiore.org