Build status - In Progress
Early Feasibility Study of the Edwards EVOQUE Tricuspid Valve Replacement System
Recruiting
18 years - 99 years
All
45 participants needed
1 Location
Brief description of study
The goal of this study is to determine the safety and performance of the Edwards EVOQUE System in patients who experience at least moderate tricuspid regurgitation and signs of, or symptoms from or prior heart failure hospitalizations for tricuspid regurgitation.
Detailed description of study
Participants will be asked to complete the following research procedures: CT scan of heart, echocardiogram, electrocardiogram, blood work, neurological exam if a history of a stroke, pulmonary function test if history of lung disease, quality of life questionnaires, and six-minute walk test. Participants will also be asked to take blood-thinning medication. These procedures are described in more detail in the below informed consent form.
Participation will last for approximately 5 years if participant receives the EVOQUE valve.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Heart,valve,cardiovascular
-
Age: 18 years - 99 years
-
Gender: All
Updated on
04 Aug 2024.
Study ID: 842666
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