Transcatheter Shunt for Heart Failure
Trial Summary
What is the purpose of this trial?
The Exploratory study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it requires participants to be on stable guideline-directed medical therapy (GDMT) for heart failure. This suggests you may need to continue your current heart failure medications.
What data supports the effectiveness of the treatment Edwards Transcatheter Atrial Shunt System for heart failure?
Is the Edwards Transcatheter Atrial Shunt System generally safe for humans?
How is the Edwards Transcatheter Atrial Shunt System treatment different from other heart failure treatments?
The Edwards Transcatheter Atrial Shunt System is unique because it involves creating a small passageway between the heart's upper chambers to help reduce pressure and improve symptoms in heart failure patients, unlike traditional treatments that often focus on medication or surgery to manage heart function.135910
Eligibility Criteria
This trial is for adults over 18 with heart failure who've been hospitalized or needed urgent treatment in the past year. They should be on stable heart medication and able to attend follow-ups for 3 years. Participants must have certain levels of elevated pressure in their hearts, as measured by specific tests.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Edwards APTURE transcatheter shunt system and are monitored for initial clinical safety, device functionality, and effectiveness
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in Qp/Qs, PCWP, PAP, RAP, PVR, and TAPSE
Treatment Details
Interventions
- Edwards Transcatheter Atrial Shunt System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
Todd Brinton
Edwards Lifesciences
Chief Medical Officer since 2023
MD from Stanford University
Bernard Zovighian
Edwards Lifesciences
Chief Executive Officer since 2023
MBA from INSEAD