Argá Medtech has announced the completion of enrolment in the paroxysmal atrial fibrillation (AF) cohort of COHERENT-AF, its pivotal US investigational device exemption (IDE) study evaluating the Coherent sine burst electroporation (CSE) platform. The paroxysmal AF cohort enrolled 150 intention-to-treat subjects across 27 sites in Europe and the USA. Enrolment in the persistent AF cohort is ongoing and expected to complete in the next two months, according to the company.
“Completing enrolment in the paroxysmal AF cohort is an important milestone for COHERENT-AF,” said Emile Daoud (Bethesda North Hospital, Cincinnati, USA), the leading enroller in COHERENT-AF. “In our procedures, the CSE platform has consistently delivered pulmonary vein isolation [PVI] with a streamlined, single-catheter workflow, and the ability to address the pulmonary veins, posterior wall and cavo-tricuspid isthmus without exchanging catheters has been a meaningful advantage in our lab. We look forward to the completion of the persistent AF cohort and the 12-month effectiveness results.”
COHERENT-AF is described by Argá Medtech as a prospective, multicentre, non-randomised premarket study evaluating the safety and effectiveness of the CSE platform in adults with symptomatic, drug-refractory paroxysmal or persistent AF. The study plan includes enrolment of up to 410 subjects in the USA and Europe, including 150 intention-to-treat subjects in each of the paroxysmal and persistent AF cohorts. Additional subjects will be enrolled in a second phase of the IDE investigation.
In the study, all subjects undergo PVI with the CSE system. Posterior wall and other left atrial substrate and cavo-tricuspid isthmus ablation types may be performed with the CSE system at the operator’s discretion. Each cohort is evaluated separately against prespecified performance goals for safety and effectiveness, with subjects followed through 12 months.
“Reaching full enrolment so quickly in the paroxysmal AF cohort reflects the commitment of our investigators and study teams,” said David Neale, chief executive officer (CEO) of Argá Medtech. “We are now focused on completing the persistent AF cohort, and generating the evidence needed to support FDA [US Food and Drug Administration] and CE-mark regulatory submissions of the CSE platform.”
The Argá Medtech CSE platform features a single ablation catheter that can be configured by a simple stylet exchange to deliver circular, linear and focal ablation lesions, the company notes in a press release. The CSE generator delivers controlled bursts of microsecond sine wave-based pulsed field ablation (PFA) across two, four or eight electrodes, and can be titrated to treat the full spectrum of atrial tissue from thin-walled right ventricle (RV) to thick septal or intramural circuits.
Argá Medtech also states that its CSE platform is an investigational device that remains limited to investigational use by US federal law.
