Conformal Medical has announced the enrolment of the first participants in the CONFORM pivotal trial of its CLAAS System.
The first patients were enrolled at two sites in the US.
The CLAAS System has been designed to seal the left atrial appendage (LAA) in non-valvular atrial fibrillation (Afib) patients to reduce stroke risk without using anticoagulants.
It features a foam matrix implant, which is designed with two sizes to address a broader range of LAA anatomies.
The new device is intended to simplify the procedure and eliminate the need for procedural transesophageal echocardiogram.
The multicentre, prospective, randomised controlled trial has been designed to assess the CLAAS System’s efficacy and safety compared to commercially available left atrial appendage occlusion (LAAO) devices.
Conformal Medical noted that the findings from the investigational device exemption (IDE) study will help the company seek pre-market approval for the device from the US Food and Drug Administration (FDA).
Approximately 1,600 subjects will be enrolled in the study at sites in the US, Japan and Canada.
Conformal Medical president and CEO Andy Levine said: “We are pleased to enrol the first patients in the CONFORM trial, an important milestone for the company.”
He added, “This IDE includes the rigour of both a randomised study comparing CLAAS to commercial devices and a separate sub-study designed to support a conscious sedation, ICE-driven approach; a critical step towards our goal to transform LAAO and reduce the risk of stroke, without the need for anticoagulants.”
As part of the company’s early feasibility studies, more than 75 patients have been successfully implanted with the CLAAS System to date.