A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)
Overview
- Phase
- Not Applicable
- Intervention
- Edwards APTURE transcatheter shunt system
- Conditions
- Heart Failure
- Sponsor
- Edwards Lifesciences
- Enrollment
- 100
- Locations
- 61
- Primary Endpoint
- Device + Medical Therapy: Subjects with Early Major Adverse Events
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
Brief Summary
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
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)
Investigators
Eligibility Criteria
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 or date of enrollment:
- •i. Within the prior 12 months, EITHER:
- •HF hospital admission (with HF as the primary or secondary diagnosis)
- •Treatment with intravenous (IV) or intensification of oral diuretics for HF
- •ii. Within the prior 6 months, EITHER:
- •BNP value \> 35 pg/ml in normal sinus rhythm (NSR) or paroxysmal atrial fibrillation (AF)
- •BNP \> 125 pg/ml for permanent or long-term persistent AF
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
Arms & Interventions
APTURE shunt + medical therapy
Intervention: Edwards APTURE transcatheter shunt system
Sham + medical therapy
Intervention: Sham procedure
Outcomes
Primary Outcomes
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.
Mean change in PCWL from baseline at 6 months
Time Frame: 6-months
Hemodynamic Effectiveness: change in pulmonary capillary wedge during load (PCWL, mmHg/W/kg) from baseline at 6 months.
Secondary Outcomes
- KCCQ-OSS change from baseline at 6-month follow-up(6-months)
- 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)
- 6MWT change from baseline at 6-month follow-up(6-months)