Edwards AP TURE transcatheter shunt system for heart failure in adults with reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an early feasibility, multicenter, prospective study evaluating the safety, device functionality, and potential effectiveness of the Edwards APTURE transcatheter shunt system in adults with heart failure and reduced ejection fraction. Eligible participants have HF with LVEF ≤40%, and symptoms ranging from NYHA class II to IVa, with recent HF events or biomarker elevations. The trial focuses on initial clinical outcomes after shunt implantation and follows patients to assess stability on optimized heart failure therapy. Data will inform whether the device can be safely implanted and whether it shows signals of clinical benefit in this population.

Why it matters

Who can join: the full rules

Refined HFrEF Subgroup Inclusion Criteria:

* A primary diagnosis of HFrEF (LVEF ≤ 40%), and
* NYHA Class II, III, or IVa heart failure symptoms and
* Documentation of at least one of the following in the past 12 months, such as:

  * Hospitalization for heart failure; or
  * Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
  * Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months.

Note: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.

* Stable Optimized GDMT - Maintained 6 months post-implant (includes stable GLP-1 RA)

Refined HFrEF Subgroup Exclusion Criteria:

* Severe HF defined as one or more of the following:

  * Ambulatory NT-proBNP value \>5,000 pg/ml or BNP value \>1,600 pg/ml
  * Left ventricular end-diastolic diameter (LVEDD) \>8 cm
  * Left ventricular ejection fraction (LVEF) \< 20%
  * ACC/AHA Stage D HF or non-ambulatory NYHA Class IV HF
  * Inotropic infusion (continuous or intermittent) within the past 6 months
  * Active listing on the cardiac transplant waiting list
* More than mild right ventricular dysfunction
* Valve disease

  * Mitral regurgitation \> moderate
  * Mitral stenosis \> mild
  * Tricuspid regurgitation \> moderate
  * Aortic regurgitation \> moderate
  * Aortic stenosis \> moderate
* Body mass index (BMI) ≥45
* Myocardial infarction and/or any therapeutic invasive, non-valvular cardiac procedure within the past 3 months, or current indication for coronary revascularization
* Stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolus within the past 6 months
* Cardiac resynchronization therapy implanted within the past 12 months
* Renal insufficiency as determined by serum creatinine (sCr) level \>2.5 mg/dL or estimated glomerular filtration rate (eGFR) \<25 ml/min/1.73 m2
* Performance of the 6-minute walk test with a distance \<100 m or \>450 m
* Active endocarditis or infection requiring intravenous antibiotics within 3 months of scheduled index procedure
* Presence of one or more of the following resting hemodynamic findings:

  1. Mean pulmonary capillary wedge pressure (PCWP) \>35 mmHg
  2. Mean right atrial pressure (RAP) \>15 mmHg
  3. Mean PCWP-mean RAP gradient \< 5 mmHg
  4. Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
  5. Cardiac index \<1.8 L/min/m2

Where it's running

• The Ohio State University Medical Center
  Columbus, Ohio, United States Recruiting
• Oklahoma Heart Institute
  Tulsa, Oklahoma, United States Recruiting
• UC San Diego Health
  La Jolla, California, United States Active not recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Withdrawn
• University California San Francisco
  San Francisco, California, United States Active not recruiting
• University of Colorado
  Aurora, Colorado, United States Withdrawn

Study contacts

• Study coordinator: Natalie Alon
• Email: Natalie_Alon@edwards.com
• Phone: 949-250-1898

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.