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JXR CARD MISS ALT FLOW

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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

Description

The early feasibility study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.

Details

Full study title Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System
Protocol number OCR49036
ClinicalTrials.gov ID NCT03523416
Phase N/A

Eligibility

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) 35 mmHg

    1. Mean right atrial pressure (RAP) >15 mmHg

    2. Mean PCWP-mean RAP gradient < 5 mmHg

    3. Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)

    4. Cardiac index

Lead researcher

  • Dominick J Angiolillo, MD, PhD
    Cardiologist (Heart Specialist), Interventional Cardiologist
    Languages: Spanish, Italian

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
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    Participate

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