Now enrolling
A prospective, multicenter, randomized, double-blind, sham-controlled trial to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system for the treatment of patients with mildly reduced (HFmrEF) or preserved (HFpEF) ejection fraction heart failure (LVEF >40%) that have elevated left atrial pressure, and who remain symptomatic despite guideline-directed medical therapy (GDMT).
Contact our Patient Support Center to find a participating hospital near you.
Heart failure is not a disease but a complex clinical syndrome with signs and symptoms that may result from many types of structural or functional impairment of ventricular filling or ejection of blood.
Left ventricular ejection fraction (LVEF) is used as a classification for patients with heart failure because of the differing prognosis and response to available treatments and therapies.1
For the diagnosis of HFmrEF and HFpEF, a patient should have an LVEF of 41% to 49% or ≥ 50%,
respectively.
Criteria for diagnosis of HFmrEF and HFpEF require evidence of increased LV filling pressures at rest and/or exercise. Additionally, patients may have elevated levels of natriuretic peptides, echocardiographic diastolic dysfunction parameters, evidence of structural heart disease such as increase in left atrial size and volume and/or an increase in LV mass.1
With diastolic dysfunction, the left ventricular wall is thickened and stiff, and it loses ability to relax as the ventricle fills. The poor filling function results in an increase of end-diastolic pressure in the left ventricle. This increases the left atrial pressure and volume and a build-up of pressure in the lungs. Patients then experience congestion and shortness of breath, along with other signs or symptoms of HF.
The heart’s limited ability to function over time, whether due to lack of pumping or filling, limits a patient’s ability to exercise or even to perform normal activities as the disease progresses over time.2
Patients will be randomized during the index procedure to treatment with the APTURE shunt (device group) or a sham-procedure (control group). Both patient groups will continue to receive GDMT.
There are two primary endpoints in this trial. The safety endpoint will assess Major Adverse Cardiovascular, Cerebrovascular, and Renal Events (MACCRE) at 30 days post index procedure or hospital discharge (for the device group only). The hemodynamic (or mechanistic) effectiveness endpoint will assess changes in Pulmonary Capillary Wedge Pressure (PCWP) at 6 months for the APTURE shunt vs. the sham controlled group.
The ALT-FLOW II trial is expected to randomize 100 patients. All patients will be followed through 5 years or until they exit the study.
The trial Central Screening Committee will determine final eligibility for patient participation. See the clinical trial protocol for a full listing of the inclusion and exclusion criteria.
6MWT=6 Minute Walk Test; BMI=Body Mass Index; BNP= B-type Natriuretic Peptide; CRT= Cardiac Resynchronization Therapy; CS=Coronary Sinus; GDMT= Guideline-Directed Medical Therapy; HF=Heart Failure; LVEF= Left Ventricular Ejection Fraction; mmHg= millimeters of mercury; NT-proBNP= N-terminal pro B-type Natriuretic Peptide; NYHA= New York Heart Association Class; PCWP=Pulmonary Capillary Wedge Pressure; PVR= Pulmonary Vascular Resistance; RAP= Right Atrial Pressure; RV= Right Ventricle; W= Watts; WU=Woods Units
The Edwards APTURE transcatheter shunt system is an investigational device intended for treatment of symptomatic heart failure patients with elevated left atrial pressure.
We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center.
For details about the trial, visit NCT05686317 at ClinicalTrials.gov.
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CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
Edwards Lifesciences is the sponsor of the ALT-FLOW II trial NCT05686317
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