Heart Failure Clinical Trial
— ALT-FLOW IIOfficial title:
A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)
NCT number | NCT05686317 |
Other study ID # | 2022-06 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2023 |
Est. completion date | October 31, 2029 |
This is a prospective, multi-center, randomized, sham-controlled clinical trial.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 31, 2029 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Edwards Lifesciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device + Medical Therapy: Subjects with Early Major Adverse Events | 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. | 30 days | |
Primary | Mean change in PCWP from baseline at 20W exercise | Hemodynamic Effectiveness: change in PCWP at 20W exercise from baseline (mmHg) at 6 months. | 6-months | |
Secondary | KCCQ-OSS change from baseline at 6-month follow-up | 6-months | ||
Secondary | 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. | 6-months | ||
Secondary | 6MWT change from baseline at 6-month follow-up | 6-months |
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