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ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)

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ClinicalTrials.gov Identifier: NCT05686317
Recruitment Status : Recruiting
First Posted : January 17, 2023
Last Update Posted : September 8, 2023
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
This is a prospective, multi-center, randomized, sham-controlled clinical trial.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Edwards APTURE transcatheter shunt system Diagnostic Test: Sham procedure Not Applicable

Detailed Description:
The objectives of this trial are to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system when used for the treatment of patients with heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (LVEF >40%) who remain symptomatic despite guideline-directed medical therapy (GDMT)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)
Actual Study Start Date : April 1, 2023
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2029
Arms and Interventions
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Arm Intervention/treatment
Experimental: APTURE shunt + medical therapy Device: Edwards APTURE transcatheter shunt system
Treatment with APTURE shunt
Sham Comparator: Sham + medical therapy Diagnostic Test: Sham procedure
CS angiography


Outcome Measures
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Primary Outcome Measures :
  1. Device + Medical Therapy: Subjects with Early Major Adverse Events [ Time Frame: 30 days ]
    Shunt implant safety: proportion of patients in the APTURE shunt group without any serious device or procedure-related (CEC adjudicated) complications (i.e., Major Adverse Cardiovascular, Cerebrovascular, and Renal Events [MACCRE]; at 30 days post index procedure or hospital discharge, whichever is later.

  2. Mean change in PCWP from baseline at 20W exercise [ Time Frame: 6-months ]
    Hemodynamic Effectiveness: change in PCWP at 20W exercise from baseline (mmHg) at 6 months.


Secondary Outcome Measures :
  1. KCCQ-OSS change from baseline at 6-month follow-up [ Time Frame: 6-months ]
  2. Proportion of individual patient success defined as being free from death, disabling stroke, and HF hospitalization with at least (≥) a 15-point improvement from baseline KCCQ-OSS or at least (≥) a 25m improvement from baseline 6MWT. [ Time Frame: 6-months ]
  3. 6MWT change from baseline at 6-month follow-up [ Time Frame: 6-months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Symptomatic heart failure

    • A primary diagnosis of HFmrEF or HFpEF (LVEF > 40%), and
    • NYHA class II to ambulatory NYHA class IV (IVa), and

  • Documentation of at least one of the following from the date of initial informed consent:

    • ≥ 1 prior HF hospitalization(s) requiring IV HF therapy in the prior 12 months; AND/OR
    • EITHER BNP value > 35 pg/ml or > 125 pg/ml in permanent or long-term persistent atrial fibrillation; OR
    • NT-proBNP > 125 pg /ml or > 375 pg /ml in permanent or long-term persistent atrial fibrillation

  • 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:

    o Pulmonary capillary wedge pressure at 20 Watts exercise (PCWP 20W) as measured at end-expiration is elevated to ≥ 25 mmHg and PCWP 20W exceeds right atrial pressure (RAP 20W) 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:

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

  • Valve disease:

    • Degenerative mitral regurgitation > moderate
    • Functional or secondary mitral valve regurgitation defined as grade > moderate
    • Mitral stenosis > mild
    • Primary or secondary tricuspid valve regurgitation defined as grade > moderate
    • 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:

    • Tricuspid annular plane systolic excursion (TAPSE) <1.4 cm, or
    • RV size ≥ LV size
    • Right ventricular ejection fraction (RVEF) < 35%; OR
    • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05686317


Contacts
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Contact: Bridget Hurley (949) 250-2265 bridget_hurley@edwards.com
Contact: Melissa Arteaga (949) 250-2002 melissa_arteaga@edwards.com

Locations
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United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Maeve McLoughlin, MPH    614-292-4084    maeve.mcloughlin@osumc.edu   
Contact: Annie Kellum    614-366-8848    annie.kellum@osumc.edu   
Principal Investigator: Scott Lilly, MD         
Principal Investigator: Rami Kahwash, MD         
Sponsors and Collaborators
Edwards Lifesciences
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT05686317    
Other Study ID Numbers: 2022-06
First Posted: January 17, 2023    Key Record Dates
Last Update Posted: September 8, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases