Medtronic initiates study evaluating potential of combination of pulmonary vein isolation and renal denervation for AF

Medtronic announced the start of a clinical study using Medtronic technologies to determine whether paroxysmal and persistent atrial fibrillation (AF) can be treated with a combination of two ablation procedures targeting different anatomical locations - specifically, the pulmonary veins and the renal arteries.

Study patients will also receive an implantable cardiac monitor to track their heart rhythm on an automatic and continuous basis. AF is a cardiac rhythm disorder affecting an estimated 2.7 million people in the US.

SYMPLICITY AF is a prospective, randomized, multi-center, feasibility clinical study investigating pulmonary vein isolation (PVI) and renal denervation compared to PVI alone, for the treatment of paroxysmal or persistent AF in patients with both AF and hypertension.

PVI will be performed with the Arctic Front Advance(TM) Cardiac Cryoablation system, and renal denervation will be performed with the Symplicity Spyral(TM) catheter and Symplicity G3(TM) radiofrequency (RF) generator. The Symplicity Spyral catheter and G3 generator are investigational in the US.

Patients in both arms of the trial also will receive a Reveal LINQ(TM) Insertable Cardiac Monitor (ICM) to automatically and continuously detect and record the net recurrence of abnormal heart rhythms after therapy randomization.

This more comprehensive method of cardiac monitoring will provide greater detail and accuracy about the treatment effect of combination therapy with PVI and renal denervation versus PVI alone. Emile G. Daoud, M.D., at The Ohio State University Wexner Medical Center enrolled the first patient in the trial.

Studies have shown that an overactive sympathetic nervous system (SNS) contributes to the development of both hypertension and AF.

Current AF therapies do not specifically address SNS over activity and historically have focused on maintenance and regulation of rate and rhythm as well as anti-coagulation to prevent stroke. Renal denervation has been shown to effectively reduce elevated SNS activity[1], and previous research has signaled that renal denervation combined with PVI may improve patient response to PVI in AF patients.

SYMPLICITY AF will enroll up to 245 patients in up to 12 centers throughout the US. 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.