Transcatheter Shunt for Heart Failure
Recruiting at 2 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Edwards Lifesciences
No Placebo Group
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.
Research Team
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
Pulmonary Vascular Resistance (PVR) < 5.0 WU as determined by site cardiologist
Left Ventricular Ejection Fraction (LVEF) ≤ 40% as determined by site cardiologist
Hemodynamic criteria: At rest - Elevated LAP (or PCWP) > 15 mmHg AND LAP > RAP + 5 mmHg AND/OR supine ergometer exercise: elevated LAP (or PCWP) > 25 mmHg AND LAP > RAP + 10 mmHg
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Exclusion Criteria
Cardiac index ≤ 1.5 L/min/m2
Left Ventricular End-Diastolic Diameter (LVEDD) > 8 cm
LVEF <20%
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Treatment Details
Interventions
- Edwards Transcatheter Atrial Shunt System (Atrial Shunt)
Trial OverviewThe study is testing the APTURE transcatheter shunt system's safety and how well it works. It's an exploratory trial involving multiple centers where participants will receive this new device designed to help manage heart failure.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Edwards APTURE transcatheter shunt systemExperimental Treatment1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
Trials
188
Recruited
67,500+
Founded
1958
Headquarters
Irvine, California, U.S.
Known For
Structural Heart Innovations
Top Products
SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3
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