This article is more than 5 years old. Information may no longer be current.
SYMPLICITY AF trial will evaluate renal denervation, pulmonary vein isolation for AF
Click Here to Manage Email Alerts
Medtronic announced that enrollment has begun for the SYMPLICITY AF study, which will assess whether paroxysmal and persistent atrial fibrillation can be treated with a combination of renal denervation and pulmonary vein isolation.
Patients will be randomized to receive pulmonary vein isolation with a cardiac cryoablation system (Arctic Front Advance, Medtronic) alone, or pulmonary vein isolation plus renal denervation with a catheter (Symplicity Spyral, Medtronic) and a radiofrequency generator (Symplicity G3, Medtronic), according to a press release from the company. Renal denervation has previously been investigated as a treatment for hypertension.
All patients in the trial will receive an insertable cardiac monitor (Reveal LINQ, Medtronic) to detect and record recurrence of abnormal heart rhythms after randomization, according to the release.
“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,” investigator Larry Chinitz, MD, director of the Heart Rhythm Center at NYU Langone Medical Center, said in the release. “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.”
The study will enroll up to 245 patients with paroxysmal or persistent AF from as many as 12 United States centers. Eligible patients will also have office-based systolic BP of 150 mm Hg or higher, despite receiving treatment with at least two antihypertensive therapies at the highest appropriate dose. Of those enrolled, 70 who meet all inclusion and no exclusion criteria will be randomized.
According to the release, the primary safety endpoint is comprised of events related to pulmonary vein isolation and renal denervation, and the primary efficacy endpoint is freedom from chronic treatment failure, defined as either AF of 30 seconds or longer or a required intervention for AF.
The renal denervation catheter and radiofrequency generator are not yet approved in the United States, and the cardiac cryoablation system is not yet approved for treatment of persistent AF, according to the release.