SYMPLICITY AF will enroll up to 245 patients in up to 12 centers throughout the United States. Seventy of these patients meeting all inclusion but no exclusion criteria and thus determined to be eligible for the trial will then be randomized to either PVI and RDN or PVI alone; all randomized subjects will receive a Reveal LINQ ICM. The primary safety endpoint is comprised of events related to both the PVI and RDN procedures. The primary efficacy endpoint will measure freedom of chronic treatment failure, defined as AF lasting 30 seconds or longer or the requirement for an intervention for atrial fibrillation through a minimum of six months. Heart rhythm data from the Reveal LINQ ICM will be reviewed monthly.
Enrollees in the trial include patients with either paroxysmal or persistent AF, and hypertension defined as office-based systolic blood pressure of >=150 mm Hg, despite treatment with two or more antihypertensive medications at the highest appropriate dose. AF is considered paroxysmal, or occasional, when the upper chambers of the heart beat erratically during self-terminating episodes lasting from a few minutes to a few days. AF is considered persistent when symptoms persist for more than seven days and medical intervention is needed to terminate the episode.
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The study will also gather feasibility outcomes data on the use of the Arctic Front Advance Cardiac Cryoablation Catheter for PVI in the persistent AF population. The Arctic Front Advance Cardiac Cryoablation system is not approved in the United States for the treatment of persistent AF; therefore, it is considered investigational in this patient population.
"The SYMPLICITY AF study, investigating three of Medtronic's notable technologies, is a groundbreaking effort and an excellent example of our commitment to driving clinical benefit through innovation," said Michael J. Coyle, executive vice president and president of Medtronic's Cardiac and Vascular Group. "Only Medtronic has the breadth and depth of cardiac-related technology to investigate new treatment and disease management strategies in this unique manner for some of the most difficult-to-treat conditions, such as AF."
About Medtronic Arctic Front Advance CryoAblation Catheter System
Treatment with the Medtronic Arctic Front Advance Cryoballoon System involves a minimally invasive procedure in which the cryoballoon fills with coolant to ablate (freeze) the tissue where the pulmonary veins enter the left atrium, blocking the abnormal electrical signals that trigger erratic heart rhythms. Delivered via a catheter, the cryoballoon technology has been associated with faster procedure times than point-by-point radiofrequency ablation.
