Argá Medtech has concluded patient enrolment for the paroxysmal atrial fibrillation (PAF) patient cohort within COHERENT-AF (NCT06784466), the pivotal investigational device exemption (IDE) study of its Coherent Sine Burst Electroporation (CSE) platform.
The study will assess the safety and effectiveness of the pulsed field ablation (PFA) system in adults with symptomatic, drug-refractory atrial arrhythmias.
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Methodologically, all treated patients undergo pulmonary vein isolation using the platform, with physicians permitted discretion to ablate the cavo-tricuspid isthmus, left atrial substrate, and posterior wall cardiac targets.
The study will measure safety and effectiveness targets separately for each cohort, monitoring all participants across a 12-month follow-up period.
The completed paroxysmal group accrued 150 patients across 27 medical centres located throughout Europe and the US, fulfilling the primary enrolment target designated for this specific arm.
Overall study protocols incorporate up to 410 patients across Europe and the US, including enrolment of 150 persistent AF participants concluding within two months, before second phase enrolment commences.
Argá’s CEO, David Neale, said: “Reaching full enrolment so quickly in the paroxysmal AF cohort reflects the commitment of our investigators and study teams.
“We are now focused on completing the persistent AF cohort and generating the evidence needed to support FDA and CE-Mark regulatory submissions of the CSE Platform.”
Technologically, the platform utilises a single catheter configured through a simple stylet exchange, allowing operators to deliver circular, focal, and linear ablation lesions during cardiac procedures.
The generator emits controlled microsecond bursts through two, four, or eight electrodes. Energy titrates across diverse cardiac tissue, from thin atrial walls to thick septal circuits.
The proprietary PFA hardware includes the SineBurst Ablation Catheter and SineWave Ablation Generator, which deliver sine-wave energy to treat patients affected by rhythm disorders.
The venture capital-backed company maintains corporate operations in Switzerland at Biopôle Lausanne in Epalinges, alongside facilities in the US located in San Diego, California.
Commercial financial backing for the medical technology enterprise is provided by an investment syndicate comprising Advent Life Sciences, Earlybird, Gilde Healthcare, High-Tech Gründerfonds, and MedFocus.
