The sham-controlled, multi-centre, prospective, double-blinded, randomised trial has been designed to evaluate the V-Wave Ventura Interatrial Shunt’s effectiveness and safety in treating HF to reduce future hospitalisations and improve the quality of life for HF patients.
In the study, 508 advanced HF patients were enrolled in 101 hospitals from 11 countries.
Patients with reduced and preserved left ventricular function etiologies for HF were also included.
The participants were randomised in a 1:1 ratio to either the Ventura Shunt treatment arm or a sham control arm.
V-Wave stated that the randomised cohort’s primary analysis will begin after the completion of the last patient’s 12-month follow-up.
The primary effectiveness follow-up of the study will range from 12 to 24 months.
The pivotal clinical trial also includes an open-label roll-in arm with an additional cohort of 97 patients, which takes the total number of patients, including both the randomised and roll-in study arms, to 605.
In the trial, the roll-in arm patients received treatment with the Ventura device.
No device- or procedure-related major adverse cardiac or neurological events have been reported so far.
V-Wave chief medical officer Dr William Abraham said: “RELIEVE-HF is the gold standard in being the most comprehensive trial of interatrial shunting in HF to date.
“We are testing this therapy in patients with both reduced and preserved left ventricular ejection fraction who are at high risk to suffer HF-related events.”
The investigational Ventura Shunt has been designed to create a small amount of blood flow from the left to the right atrium, which is required for reducing elevated left atrial pressure.
The shunt is implanted during a standard minimally invasive catheter-based procedure.
The device has received CE Marking in the EU and Breakthrough Device Designation from the US Food and Drug Administration (FDA).