Argá Medtech has announced initial enrolments in the COHERENT-AF pivotal clinical trial. This US Food and Drug Administration (FDA) investigational device exemption (IDE), prospective, non-randomised trial is designed to evaluate the safety and effectiveness of the Coherent Sine-Burst Electroporation (CSE) pulsed field ablation (PFA) system in patients with paroxysmal and persistent atrial fibrillation (AF), and will enrol up to 360 patients across clinical sites in the USA and Europe.
The first patients were treated by Ante Anic at KBC Split Hospital (Split, Croatia). Post-procedure, all patients were doing well and have subsequently been released from hospital to continue their recovery, an Argá Medtech press release reports.
“The flexibility of the CSE platform fills a gap when treating patients beyond pulmonary vein isolation,” Anic noted following the procedures. “The single, stylet-driven, multi-configurable ablation catheter easily transitions to deliver linear and focal ablations providing procedural efficiencies when treating both paroxysmal and persistent AF patients, and adds an additional layer of safety by eliminating catheter exchanges.”
The CSE system has been used in more than 100 patients to date, demonstrating greater than 94% lesion durability at three months, 92.6% freedom from atrial arrhythmias at six months and a 1% adverse event rate in Argá Medtech’s initial BURST-AF clinical study.
“Initiation of COHERENT-AF is a major milestone for Argá Medtech,” said David Neale, the company’s chief executive officer (CEO). “It marks the start of our journey to bring a next-generation, safe, fast and effective ablation treatment to the millions of people affected by cardiac rhythm disorders and AF.”
Argá Medtech’s claims that its CSE PFA platform—with its proprietary CSE PFA generator and a multi-configurable catheter—brings “unmatched flexibility” to the treatment of AF, and offers several advantages over other PFA platforms, which are typically powered by square wave energy sources. The CSE system uses a sinusoidal/sine wave, allowing physicians to configure the energy delivery to achieve a transmural lesion for different depths of the tissue to be ablated. The waveform is delivered through a versatile, all-in-one catheter that can be shaped to create circular, linear or focal ablation lesions, eliminating the need to perform catheter exchanges to achieve the desired treatment strategy. This simplifies the procedure, reduces the risk of introducing air bubbles as one catheter is removed and another is reinserted, and reduces costs, according to the company.
