Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: A Pilot Study
The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).
• Age ≥ 18
• Planned for a first-ever AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as involving pulmonary vein isolation, 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)
• History of hypertension and either:
‣ Documented history of SBP ≥ 160 or DBP ≥ 100 (Stage III), or
⁃ Receiving ≥ 1 antihypertensive medication
• Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements