IRB Study Number 19-1393
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The objective of this trial is to evaluate the safety and effectiveness of the TriClip™ device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR) who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
Inclusion Criteria
- Subject has been adequately treated per applicable standards and stable for at least 30 days, as determined by site heart team
- Subject is symptomatic with Severe TR despite being optimally treated (TR severity will determined by Transthoracic Echocardiogram (TTE) & assessed by the Echocardiography Core Lab)
- Cardiac surgeon of local heart team concurs that patient is at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery
- Further inclusion criteria will be assessed by study staff
Exclusion Criteria
- High systolic pulmonary artery pressure or fixed pre-capillary pulmonary hypertension as& defined by study protocol & assessed by right heart catheterization (RHC)
- Severe uncontrolled hypertension as defined by study protocol
- Any prior tricuspid valve procedure that would interfere with placement of the TriClip™ device
- Further exclusion criteria will be assessed by study staff
