Atricure have announced that the enrolment of the full cohort of 153 patients in the CONVERGE IDE clinical trial has been completed. CONVERGE IDE is the first prospective, randomised study comparing the Convergent approach to endocardial catheter ablation in persistent and long-standing persistent atrial fibrillation (AF) patients
The CONVERGE IDE trial is a landmark prospective, randomised trial underway in the United States comparing the Convergent approach to endocardial catheter ablation for patients with persistent or long-standing persistent AF. The Convergent approach is a multi-disciplinary therapy in which a closed-chest epicardial ablation is performed by a surgeon, and then complemented by an endocardial catheter ablation performed by an electrophysiologist. Patients were enrolled at 25 sites across the USA, along with two sites in the UK.
The CONVERGE study’s primary efficacy endpoint is for enrolled patients to be AF, atrial tachycardia, and atrial flutter free, absent class I and III AADs except for a previously failed or intolerant class I or III anti-arrhythmic drugs, with no increase in dosage following the 3-month blanking period through the 12 months’ post procedure follow-up visit. The last patient follow-up is expected to be sometime in the third quarter of 2019, after which the company will submit final documentation to the US Food and Drug Administration and seek a pre-market approval (PMA).
“The CONVERGE trial is an important step forward for the cardiology community in furthering available treatment options for Afib patients,” said David De Lurgio, principal investigator for the trial, and Director of Electrophysiology at Emory Heart and Vascular Center in Atlanta, USA. “This study is differentiated from other studies currently being conducted on the persistent and long-standing persistent population, because there is no time restriction on the duration of diagnosed AF in the patients being studied. Patients with persistent and long-standing persistent AF make up a very large percentage of the diagnosed population, and the trial is intended to study the safety and effectiveness of the Convergent approach for those patients that have limited other options for effective treatment.”