The Fridley, Minn.-based medical device giant said the 245-patient Symplicity AF trial is a prospective, randomized, multi-center feasibility study. It’s designed to compare RDN and pulmonary vein isolation using a cardiac ablation catheter with PVI alone, Medtronic said.
Symplicity AF is for patients with paroxysmal or persistent afib in patients with both afib and hypertension, using Medtronic’s Arctic Front Advance cryoablation system and Symplicity Spyral RDN system. Seventy patients will be randomized to either PVI alone or the combination treatment; all will be implanted with the Reveal Linq cardiac monitor.
The primary safety endpoint is a composite of PVI -and RDN-related events, Medtronic said; the primary efficacy endpoint is freedom from AF lasting 30 seconds or longer, or requiring intervention, for a minimum of 6 months. Symplicity AF is also designed to collect feasibility outcomes data on the Arctic Front Advance device in persistent AF, the company said.
"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," principal investigator Dr. Larry Chinitz of the NYU Langone Medical Center said in prepared remarks. "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 Symplicity AF study, investigating 3 of Medtronic’s notable technologies, is a groundbreaking effort and an excellent example of our commitment to driving clinical benefit through innovation," added executive vice president Michael Coyle. "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."
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