Medtronic initiates atrial fibrillation clinical trial using Cardiac CryoAblation Catheter
Tuesday, April 4, 2017
Source: Becker's Hospital Review
Minneapolis-based Medtronic on March 30 launched the enrollment for its Stop Persistent AF clinical trial.
The clinical trial will assess the safety and effectiveness of a pulmonary vein isolation-only strategy to treat patients with persistent atrial fibrillation using the company's Arctic Front Advance Cardiac CryoAblation Catheter.
The trial will enroll up to 225 patients at 25 healthcare facilities in the U.S., Canada, Europe and Japan, according to a company news release. Researchers will follow patients for one year following the initial cryoballon ablation procedure.
"Gaining meaningful data from this trial will help further clinicians' understanding of possible treatment options for patients with persistent AF," said co-principal investigator Hugh Calkins, MD, director of the electrophysiology laboratory and arrhythmia service at Baltimore-based Johns Hopkins Hospital. "As AF progresses and episodes become more constant, patients' quality of life diminishes while their risk of AF-related health effects, such as heart failure and stroke, increases. This trial could help us advance care for this hard-to-treat population."