Medtronic Study Evaluates Paroxysmal, Persistent Atrial Fibrillation Treatments
Monday, May 4, 2015
Source: FDA News
Medtronic has initiated a clinical trial evaluating treatment of paroxysmal and persistent atrial fibrillation by using two different ablation procedures, the Ireland-based devicemaker announced Thursday.
The multicenter study will investigate pulmonary vein isolation and renal denervation, and compare it with PVI treatment alone, for patients suffering from AF and hypertension.
To that end, PVI procedures will use the devicemaker’s Arctic Front Advance Cardiac Cryoablation system while renal denervation procedures will use the devicemaker’s Symplicity Spyral catheter and Symplicity G3 radiofrequency generator. Patients enrolled in the study will be implanted with a cardiac monitor to assess their heart rhythms at all times.
The study’s primary efficacy endpoint measures freedom of chronic treatment failure, which is stated as AF lasting 30 seconds or longer or the need for an intervention for AF through a six-month minimum.
The FDA has designated the Symplicity Spyral catheter and G3 generator for investigational use.