Ultrasound-Based Renal Sympathetic Denervation As Adjunctive Upstream Therapy During Atrial Fibrillation - Redo Ablation Procedures: a Pilot Study
This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial. The purpose of the study is to determine the role of adjunctive renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension scheduled for a redo AF ablation procedure for paroxysmal or persistent AF. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).
• Age ≥ 18;
• Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as successful pulmonary vein isolation, if needed, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation, must have been completed). Note: the clinical recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the dominant recurrent rhythm.)
• History of hypertension and either:
‣ Documented history of SBP≥160 or DBP≥100, or;
⁃ Receiving ≥1 antihypertensive medication;
• Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements