New trial to assess cryoballoon ablation for early persistent AF

Medtronic announced initiation of the Cryo4 Persistent AF clinical trial, which will assess 12-month clinical outcomes of cryoballoon ablation for pulmonary vein isolation in patients with early persistent atrial fibrillation, according to a press release.

Researchers will evaluate use of the Arctic Front Advance Cryoballoon System, which involves a minimally invasive procedure by which the cryoballoon inflates and fills with coolant to ablate the tissue in the upper chamber of the heart, according to the release. The purpose is to assess the single-procedure outcomes of cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram ablations for patients with early persistent AF, according to information from ClinicalTrials.gov.

The multicenter, prospective, nonrandomized, postmarket trial will monitor patients for 12 months after ablation with the Arctic Front Advance Cryoballoon System for adjudicated AF, atrial flutter or atrial tachyarrhythmias lasting longer than 30 seconds. Secondary outcome measures include acute procedural success, sinus rhythm restoration followed by chronic prevention of AF recurrence, use of class I and III antiarrhythmic drugs, changes in quality of life and adverse events related to the procedure, according to ClinicalTrials.gov.

Anticipated enrollment is 130 patients at 10 centers in France and Germany. The estimated primarily completion date is September 2016, according to ClinicalTrials.gov.

In the United States, the system is currently approved by the FDA for patients with drug-refractory, recurrent, symptomatic, paroxysmal AF.

Disclosure: The trial is sponsored by Medtronic Atrial Fibrillation Solutions

Source: www.healio.com