Biosense Webster has announced that a study it is sponsoring, the Atrial Fibrillation Progression Trial (ATTEST), has started to enrol patients and will investigate the impact of early radiofrequency ablation on the progression of drug-refractory paroxysmal atrial fibrillation to persistent atrial fibrillation.
The prospective, multicentre, randomised, controlled study will compare pulmonary vein isolation (using Biosense Webster’s ThermoCool catheters and the company’s Carto 3 or Carto XP mapping systems) with drug therapy (rate or rhythm control) in patients with paroxysmal atrial fibrillation. The primary endpoint is the time to the development of persistent atrial fibrillation and secondary endpoints include the safety of the treatment options being investigated and the influence of comorbidities on atrial fibrillation progression.
Lead investigator Karl-Heinz Kuck, Asklepios Klinik, St Georg, Hamburg, Germany, announced the launch of the ATTEST study at the recent Boston AF2012 meeting (12–14 January, Boston, USA). He said the primary endpoint was a new focus of investigation in atrial fibrillation research. He added: “We do not care for paroxysmal atrial fibrillation, atrial fibrillation recurrence, and we do not care for mortality. We care for the conversion into the persistent forms of atrial fibrillation.”
He added that he and his fellow investigators were looking to recruit patients who have had recurrent episodes of paroxysmal atrial fibrillation for two years with more than six episodes over the last six months. The ultimate aim is to recruit approximately 330 patients at up to 50 sites primarily in Europe and Asia. The trial is scheduled to last four to five years, including three years of follow-up.
Marcia Yaross, vice president, Worldwide Clinical, Regulatory and Healthy Policy, Biosense Webster, said in a press release: “The evidence for superiority of catheter ablation versus drug therapy in appropriately selected paroxysmal atrial fibrillation patients is now classified as level A based on outcomes through one year, including freedom from recurrence and improved quality of life. We are committed to growing the evidence base by supporting studies such as ATTEST to evaluate the potential for long-term prevention of atrial fibrillation disease progression as part of our commitment to improving the lives of people with arrhythmias.”