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Testing a new heart shunt system for patients with heart failure

A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)

Not applicable Interventional Edwards Lifesciences · NCT05686317

This study is testing a new heart shunt system to see if it can help patients with heart failure feel better when their current treatments aren't working.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorEdwards Lifesciences Industry-sponsored
Locations30 sites (Irvine, California and 29 other locations)
Trial IDNCT05686317 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Edwards APTURE transcatheter shunt system in treating patients with heart failure who have preserved or mildly reduced ejection fraction. It is a multi-center, randomized, sham-controlled, and double-blinded trial, meaning neither the participants nor the assessors know who receives the actual treatment versus a placebo. The study focuses on patients who continue to experience symptoms despite receiving standard medical therapy. The trial aims to gather data on the performance of this innovative device in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults with symptomatic heart failure, specifically those diagnosed with HFpEF or HFmrEF and classified as NYHA class II to IV.

Not a fit: Patients with heart failure who do not meet the inclusion criteria or have more advanced heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from heart failure.

How similar studies have performed: Other studies have explored similar transcatheter approaches for heart failure, showing promising results, but this specific device's effectiveness is still under investigation.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

• Symptomatic heart failure

1. A primary diagnosis of HFmrEF or HFpEF (LVEF \> 40%), and
2. NYHA class II to ambulatory NYHA class IV (IVa), and
3. Documentation of at least one of the following from the date of initial informed consent or date of enrollment:

i. Within the prior 12 months, EITHER:

* HF hospital admission (with HF as the primary or secondary diagnosis)
* Treatment with intravenous (IV) or intensification of oral diuretics for HF

ii. Within the prior 6 months, EITHER:

* BNP value \> 35 pg/ml in normal sinus rhythm (NSR) or paroxysmal atrial fibrillation (AF)
* BNP \> 125 pg/ml for permanent or long-term persistent AF
* NT-proBNP \> 125 pg/ml in NSR or paroxysmal AF
* NT-proBNP \> 375 pg/ml for permanent or long-term persistent AF d. There is objective evidence of cardiogenic pulmonary congestion based on hemodynamic criteria obtained by right heart catheterization (RHC) at exercise, and confirmed by hemodynamics core lab as: As measured at end-expiration, pulmonary capillary wedge pressure (PCWP) at ≥ 20 Watts exercise (PCWP ≥ 20W) is elevated to ≥ 25 mmHg and exceeds \[the corresponding\] right atrial pressure (RAP) by ≥ 8 mmHg • In the judgment of the treating physician and the Central Screening Committee the patient is on GDMT for HFpEF/HFmrEF for \>30 days prior to screening and baseline assessments, that is expected to be maintained without change for 6 months.

Key Exclusion Criteria:

* Severe heart failure defined as one or more of the below:

  1. ACC/AHA/ESC Stage D HF, non-ambulatory NYHA Class IV HF
  2. If Body Mass Index (BMI) \< 30, cardiac index \< 2.0 L/min/m2
  3. If BMI ≥ 30, cardiac index \< 1.8 L/min/m2
  4. Inotropic infusion (continuous or intermittent) within the past 6 months
  5. Patient is on the cardiac transplant waiting list
  6. Prior diagnosis of HF with reduced ejection fraction (HFrEF), including patients with improvement in LVEF to \> 40%
* Valve disease:

  1. Degenerative mitral regurgitation \> moderate
  2. Functional or secondary mitral valve regurgitation defined as grade \> moderate
  3. Mitral stenosis \> mild
  4. Primary or secondary tricuspid valve regurgitation defined as grade \> moderate
  5. Aortic valve disease defined as aortic regurgitation grade \> moderate or aortic stenosis \> moderate
* More than mild right ventricular (RV) dysfunction as determined by the echo core lab, taking into account the following available parameters:

  1. Tricuspid annular plane systolic excursion (TAPSE) \<1.4 cm, or
  2. RV size ≥ LV size
  3. Right ventricular ejection fraction (RVEF) \< 35%; or
  4. Imaging or clinical evidence of congestive hepatopathy
* Mean right atrial pressure (mRAP) \> 15 mmHg at rest
* Pulmonary vascular resistance (PVR) ≥ 5.0 WU
* BMI ≥ 45
* Myocardial infarction (MI) and/or any therapeutic invasive, non-valvular cardiovascular procedure within past 3 months or current indication for coronary revascularization
* Stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT) or pulmonary embolus within the past 6 months
* Renal insufficiency as determined by creatinine (sCr) level \> 2.5 mg/dL or estimated glomerular filtration rate (eGFR) \< 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis
* Performance of the six-minute walk test (6MWT) with a distance \< 50m OR \> 450m
* Active endocarditis or infection requiring intravenous antibiotics within 3 months

Where this trial is running

Irvine, California and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Failure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.