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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