Adagio Medical announced that it enrolled the first patient in its iCLAS investigational device exemption clinical trial for assessing the treatment for persistent atrial fibrillation.
The iCLAS is a low-temperature intelligent continuous legion ablation system. The FDA-approved study has the goal of evaluating the safety and efficacy of the system in PsAF to support pre-market approval application. Dr. Suneet Mittal enrolled the first patient at the Valley Hospital in Ridgewood, N.J.
When IDE approval was announced, Adagio said the 12-month study was slated to treat patients with one of the two types of its cryoablation catheter, the One Shot or One Shot+. The catheter is designed to make true, continuous, transmural lesions and combine ablation and diagnostics in the same catheter, needing just one single transseptal puncture.
The previously announced 80-patient study, a non-randomized, single-arm trial of subjects with persistent afib, will use the Laguna Hills, Calif.-based company’s intelligent continuous lesion ablation system to treat patients with afib of more than one week but less than a year, who have not previously had ablation therapy.
The primary safety endpoints are procedural adverse events at one day, seven days, 30 days and one year; the primary efficacy endpoints are the rate of complete pulmonary vein isolation, termination of afib and complete linear block if applicable, all at one day.
“We are privileged to work with leading electrophysiologists to advance the treatment of atrial fibrillation,” Adagio CEO Olav Bergheim said in a news release. “Current ablation therapies are used to treat less than 5% of eligible patients due to disappointing clinical outcomes, long procedure times and unsatisfactory profitability for the providers. The Adagio procedure aims to transform ablation therapy by addressing each of these challenges, making catheter ablation therapy available to the broader AFib patient population.”
“We are pleased to be the first site to enroll a patient in this study,” added Mittal. “This novel cryoablation system offers multiple advantages, including a single catheter to address all ablation needs, irrespective of whether right or left atrium is targeted for ablation, no 3D mapping required, and more comprehensive lesion sets may favorably impact long-term results of ablation in this difficult to treat patient population.”