Medtronic has announced the initiation of a randomised clinical trial in Europe to assess the benefits of ablation using the Medtronic Arctic Front Advance cryoballoon as a first-line treatment for atrial fibrillation patients. While medication is currently considered first-line treatment, clinical research indicates that half of all patients with symptomatic disease do not respond to drug therapy. Medtronic believes that earlier ablation may improve treatment effectiveness.
The Cryo-FIRST (Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation) trial will evaluate the procedural success and clinical outcomes of patients with paroxysmal atrial fibrillation undergoing cryoballoon ablation as an initial treatment compared with medication. It will include approximately 218 patients in up to 12 centres across Europe; enrolments have occurred at Heart Rhythm Management Centre, UZ Brussel-VUB Brussel, Brussels, Belgium; Clinique Saint Gatien, Tours, France; CHU d’Amiens, Amiens, France, and Kerckhoff-Klinik, Bad Nauheim, Germany.
The most recent European guidelines highlight that ablation should be considered as first-line therapy in selected patients with symptomatic paroxysmal atrial fibrillation. Cryoballoon ablation is not approved as a first-line treatment in the USA.
Cryoablation involves a minimally invasive procedure that creates lesions by freezing tissue in the heart’s upper chambers, traditionally around the pulmonary veins, to block the electrical signals that trigger erratic heart rhythms. Pulmonary vein isolation is a standard treatment for patients in the early stages of atrial fibrillation when the triggers come largely from these veins. However, as the disease progresses, it becomes more complicated to treat, with lower long-term success rates.
“For select patients with symptomatic paroxysmal atrial fibrillation and minimal or no heart disease, this therapy-with its established safety profile-has potential as a first-line treatment, providing valuable clinical insights and evidence for future therapeutic solutions,” said Heinz-Friedrich Pitschner, Kerckhoff-Klinik Heart Center, and chair of the Cryo-FIRST steering committee.
“With the prevalence of atrial fibrillation expected to increase exponentially over the next generation, we believe that cryoballoon ablation therapy may safely and effectively address the disease before it progresses, improving outcomes and quality of life for patients, and reducing healthcare costs,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions business.