“The CONVERGE study is a monumental step forward in the market focused on the most difficult to treat Afib patients, those with persistent or long-standing persistent forms of the disease,” said Michael Carrel, president and CEO at AtriCure. “This patient population represents many millions of patients and more than two-thirds of all diagnosed Afib patients. The study results presented at HRS mark a major milestone for the CONVERGE study and we look forward to working with the FDA moving forward.”
The CONVERGE IDE trial’s primary effectiveness endpoint is freedom from Afib, atrial tachycardia (AT), and atrial flutter (AFL), absent class I and III anti-arrhythmic drugs (AADs) except for a previously failed or demonstrated intolerance to class I or III AADs, with no increase in dosage following the three-month blanking period through the 12-months post procedure follow-up visit. The primary safety endpoint is the incidence of protocol-defined major adverse events (MAEs) for subjects undergoing the Convergent procedure from the time of the intervention through 30-days post intervention. There were no deaths, cardiac perforations or atrio-esophageal fistulas reported in the trial. Dr. DeLurgio presented the MAE rate of 7.8 percent in treatment arm, which was lower than the protocol pre-specified performance goal of 12 percent. There were also no long-lasting safety events observed in the trial. More detail can be found here.
The trial enrolled 153 patients at 27 locations (25 in the United States and 2 in the United Kingdom). Patients were randomized at a rate of 2:1 and received either the hybrid Convergent procedure or an endocardial catheter ablation alone. Dr. David DeLurgio, M.D., of Emory St. Joseph’s Hospital in Atlanta, was the trial’s national principal investigator.
“This is one of the most highly anticipated trials in the Afib space in many years because of the potential to effectively treat patients who are difficult to treat. I’m very pleased about the results of the trial, which showed an 18 percent difference between the Convergent arm and the control arm in evaluable patients at 12 months,” said Dr. DeLurgio. “Additionally, the measure of Afib burden reduction of greater than 90 ercent was remarkable and much better than expected. The data presented showed a greater than 23 percent advantage for the Convergent arm over the control arm. Based on these findings, epicardial and endocardial ablation using the hybrid Convergent procedure could prove to be a preferred therapy for patients with advanced forms of Afib.”
Afib affects over 33 million people worldwide and approximately 70 percent have persistent and longstanding persistent Afib.1 Afib increases the risk of stroke and is linked with increased risk of mortality.
“Most importantly, in keeping with the AtriCure mission, we look forward to working interactively with the FDA towards the approval of the therapy, which will facilitate targeted training and a more informed physician-patient discussion,” said Mr. Carrel.
The EPi-Sense device and hybrid procedure are investigational and not approved in the US for the treatment of Afib. The data analyses presented have not been reviewed by FDA.
The CONVERGE IDE trial is a landmark prospective, superiority, randomized controlled pivotal trial to evaluate the overall success of the hybrid Convergent ablation to endocardial catheter ablation for patients with persistent or long-standing persistent Afib. The procedure combines a minimally invasive, closed chest epicardial ablation performed by a surgeon with endocardial catheter ablation performed by an electrophysiologist.
1 Berisso et al. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014; 6: 213–220.