EFFECT OF RENAL DENERVATION ON ATRIAL FIBRILLATION (ERDAF)

Abstract

Objective: Renal sympathetic denervation (RDN) is a novel minimally invasive therapeutic option for patients with resistant arterial hypertension (AH). Recent data has shown that RDN with or without pulmonary vein isolation (PVI) may also have a positive impact on the management of patients with paroxysmal or persistent atrial fibrillation (AF). The purpose of the ERDAF study (Effect of Renal Denervation on Atrial Fibrillation) is to evaluate the renal sympathetic denervation in patients with resistant AH and symptomatic paroxysmal or persistent AF in order to show if there is a reduction in the AF-related symptoms, the AF recurrence rate, and the total burden (symptomatic and/or asymptomatic) of the arrhythmia. Design and method: This is a single-center, randomized study, in which thirty (30) consecutive patients > 18 years with resistant hypertension and symptomatic paroxysmal or persistent AF will be included after the restoration of the sinus rhythm. Patients will be randomized in a 1:1 ratio to either sympathetic transcatheter RDN on top of drug therapy (n = 15) or only conservative management with drug therapy (n = 15)(Figure). An implantable loop recorder (ILR) will be implanted subcutaneously in all patients after their study enrollment for long cardiac rhythm monitoring. Symptoms of arrhythmia will be evaluated based on the EHRA score. Patients will be monitored for a period of 18 months after the ILR implantation. Results: The first three months after RDN will be excluded from our final analysis (blanking period). Follow-up visits will be scheduled for the first month and every three months thereafter for a period of 18 months. Conclusions: The primary endpoint will be the change in the total AF burden (Total time in AF during the follow-up period). Secondary endpoints will include the change in the symptomatic and asymptomatic burden of AF, the time to detect the first AF recurrence (symptomatic and/or asymptomatic)-early recurrence of AF after RDN, and the change in blood pressure (systolic, diastolic and mean blood pressure) during the follow-up period.