At a glance
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Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
In Brief
A clinical study evaluating Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter and Arctic Front Advance™ Cardiac Cryoablation System for Atrial Fibrillation and Hypertension. Completed, enrolled 102 participants across 10 sites in 2 countries.
Detailed Summary
The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension. To assess safety, the study will measure the occurrence of a composite safety endpoint and, to assess effectiveness, the study will measure freedom of chronic treatment failure through a minimum of six months of follow-up.