NCT03523416 · Edwards Lifesciences
Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
(ALT-FLOW US)
What this study is about
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.
View original scientific description
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.
Interventions
DEVICE
Edwards APTURE transcatheter shunt system
Transcatheter treatment of symptomatic heart failure patients with elevated left atrial pressure.
Primary outcome measures
Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)
Time frame: 30 days
Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Mean pulmonary capillary wedge pressure (PCWP) \>35 mmHg
- Mean right atrial pressure (RAP) \>15 mmHg
- Mean PCWP-mean RAP gradient \< 5 mmHg
- Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
- Cardiac index \<1.8 L/min/m2
Where
- La Jolla, California
- Los Angeles, California
- San Francisco, California
- Aurora, Colorado
- Jacksonville, Florida
- Indianapolis, Indiana
- Kansas City, Kansas
- Minneapolis, Minnesota
- Rochester, Minnesota
- Morristown, New Jersey
- The Bronx, New York
- Charlotte, North Carolina
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2026 · Source of record for eligibility and locations