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Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW US)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the early safety of the Edwards APTURE transcatheter shunt system and how well it works. It is for people with heart failure whose heart pumps less blood than normal.

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your main diagnosis is heart failure with reduced pumping strength (HFrEF). Your heart’s pumping measure, called LVEF, is 40% or less.
  • You have heart failure symptoms rated NYHA Class II, III, or IVa, which describe how much symptoms limit activity.
  • If you have Class II symptoms, you must have both worsening heart failure in the past 12 months and high blood markers of heart failure in the past 6 months.
  • If you have Class III or IVa symptoms, you must have either worsening heart failure in the past 12 months or high blood markers in the past 6 months.
  • Worsening heart failure means a hospital stay or more treatment, such as water-removal medicine given through a vein or at a higher dose.
  • You are on stable, optimized heart failure medicines and stay on them for 6 months after the implant. This includes stable GLP-1 RA medicine.

Who can't join

  • Very severe heart failure: NT-proBNP blood level above 5,000 pg/ml or BNP above 1,600 pg/ml; left heart pumping chamber wider than 8 cm when filled; LVEF below 20%; Stage D or non-ambulatory Class IV heart failure; heart-strengthening medicine through a vein in the past 6 months; or an active heart transplant listing.
  • More than mild weakness of the right heart pumping chamber; more than moderate leaking of the mitral, tricuspid, or aortic valve; more than mild narrowing of the mitral valve; or more than moderate narrowing of the aortic valve.
  • Body mass index (BMI), a measure based on height and weight, of 45 or higher; or walking less than 100 meters or more than 450 meters in a 6-minute walk test.
  • Heart attack or an invasive heart treatment not involving a valve in the past 3 months; a current need for treatment to restore blood flow to the heart; or a device to coordinate heartbeats implanted in the past 12 months.
  • Stroke, mini-stroke, a blood clot in a deep vein, or a blood clot in the lungs in the past 6 months.
  • Poor kidney function: blood creatinine above 2.5 mg/dL or estimated kidney filtering rate below 25 ml/min/1.73 m².
  • Active infection of the heart’s inner lining, or an infection needing antibiotics through a vein within 3 months of the planned procedure.
  • Certain abnormal heart measurements at rest: pressure backing up toward the lungs above 35 mmHg; right upper heart chamber pressure above 15 mmHg; a difference between these pressures below 5 mmHg; resistance in lung blood vessels of 5 Wood units or higher; or blood pumped relative to body size below 1.8 L/min/m².

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (19)

CA

CO

FL

IN

KS

MN

NC

NJ

NY

OH

OK

OR

PA

SC

WA