Feasibility of the Edwards APTURE transcatheter shunt for symptomatic HFrEF with high filling pressures

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 a prospective, multicenter, open-label, single-arm feasibility study assessing the safety and performance of the Edwards APTURE shunt in symptomatic HFrEF patients with elevated left atrial pressure. Participants are adults with LVEF ≤40% and NYHA II–IVa symptoms, who have had recent heart failure events or biomarker elevation, and who are on stable guideline-directed medical therapy. The study aims to provide early safety data, evaluate device functionality, and generate guidance for future trials and device design. Enrolment spans multiple centers in Germany, with a focus on real-world clinical settings and evolving patient selection criteria. Outcomes emphasize safety, device performance, and preliminary effectiveness signals to inform subsequent investigations.

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), indicated device therapy, and comorbidity management.

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, or unmet guideline-directed indication for CRT
* 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
* Baseline resting heart rate \>100 bpm

Where it's running

• Herzzentrum Dresden GmbH Universitätsklinik für Innere Medizin und Kardiologie
  Dresden, Germany, Germany Recruiting
• Johannes Gutenberg Universitaet Mainz
  Mainz, Germany, Germany Recruiting
• Herzzentrum Universitätsklinikum Köln
  Cologne, Germany, Germany Not yet recruiting

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.