International Multisite Transcatheter Tricuspid Valve Therapies Registry

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.
Brief Title
International Multisite Transcatheter Tricuspid Valve Therapies Registry
Central Contacts
Central Contact Role
Contact
Central Contact Phone
0041442553728
Central Contact Email
maurizio.taramasso@usz.ch
Completion Date
Completion Date Type
Estimated
Conditions
Severe Tricuspid Regurgitation
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
Inclusion 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

Gender
All
Gender Based
false
Keywords
Tricuspid Valve
tricuspid regurgitation
transcatheter tricuspid regurgitation
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT03416166
Org Class
Other
Org Full Name
University of Zurich
Org Study Id
2016-01753
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
International Multisite Transcatheter Tricuspid Valve Therapies Registry
Primary Outcomes
Outcome Measure
Cardiovascular Death
Outcome Time Frame
30 days
Secondary Outcomes
Outcome Time Frame
30 days, 1 year
Outcome Measure
NYHA Class
Outcome Time Frame
30 days, 1 year
Outcome Measure
TR Reduction
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Study Population
Patients with severe symptomatic tricuspid regurgitation
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mohamed Azeem Latib
Investigator Email
mlatib@montefiore.org
Investigator Phone
646-773-2076