Enrollment Underway in the U.S. for Groundbreaking Study Involving Three Medtronic Devices: Arctic Front Advance(TM) Cryoballoon, Symplicity Spyral(TM) & Reveal LINQ(TM) ICM

DUBLIN - Medtronic plc (NYSE: MDT) today 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 U.S.

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 United States.


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.

"Hypertension is one of the most prevalent risk factors for developing AF, but we've seen that it is also potentially the most modifiable risk factor for halting the progression of the disease," said principal investigator Larry Chinitz, M.D., director, Heart Rhythm Center, NYU Langone Medical Center in New York. "As we continue to look for ways to prevent AF recurrence and improve outcomes for patients with AF, this trial may reveal a potential new treatment path for patients."

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.[2]

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