Adjunctive Renal Sympathetic Denervation to Modify Hypertension as Upstream Therapy in the Treatment of Atrial Fibrillation (H-FIB) Study: Clinical Background and Study Design
Biosense Webster is the sponsor of this trial; it played no role in the collection or analysis of data.
Drs. D'Avila and Reddy have received consulting fees from Biosense Webster. Other authors: No disclosures.
Address for correspondence: Vivek Y. Reddy, M.D., Helmsley Electrophysiology Center, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1030, New York, NY 10029. Fax: +646-537-9691; E-mail: firstname.lastname@example.org
Adjunctive Renal Sympathetic Denervation to Modify Hypertension
Hypertension is the most important risk factor directly attributable to the high prevalence of atrial fibrillation (AF), and is one of the few modifiable risk factors for AF. Activation and overactivity of the sympathetic nervous system (SNS) have been implicated in the pathogenesis of both essential hypertension and AF. Catheter-based renal sympathetic denervation (RSDN) appears to be an effective adjunctive treatment for refractory hypertension, and may be beneficial in other conditions characterized by SNS overactivity, such as left ventricular hypertrophy and atrial arrhythmias.
The H-FIB study is a multicenter prospective, double-blind, randomized (1:1) controlled trial. The primary efficacy endpoint is antiarrhythmic drug-free freedom from AF recurrence through 12 months.
Patients with a history of significant hypertension who are receiving treatment with at least one antihypertensive agent who are planned for a first time ablation for symptomatic paroxysmal or persistent AF will be randomized to either AF ablation alone (control group) or AF ablation + RSDN (study group).
H-FIB is a multicenter, randomized trial that will test the hypothesis that adjunctive renal sympathetic denervation, at the time of AF ablation, will increase the freedom from recurrent AF.