No phaseRecruiting
Early Feasibility Study - Edwards APTURE Transcatheter Shunt System (ALT-FLOW US)
Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW US)
- Sponsor
- Edwards Lifesciences (Industry)
- Enrolment
- 90 planned
- Conditions
- Heart Failure
- Interventions
- Edwards APTURE transcatheter shunt system
- Ages
- adults, older adults
- Registry
- NCT03523416
From the registry
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.
Primary outcomes
- Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)