~6 spots leftby Apr 2026

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
See 2 more

Exclusion Criteria

Cardiac index ≤ 1.5 L/min/m2
Left Ventricular End-Diastolic Diameter (LVEDD) > 8 cm
LVEF <20%
See 10 more

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 profile image

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian profile image

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD