NCT04182620

Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation

Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Vivek Reddy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of 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). This is a prospective, controlled, single-blind, randomized trial. The pilot study will be conducted in up to 11 clinical sites in the United States and Europe.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	renal denervation	Renal denervation using the Paradise renal denervation system - a dedicated RDN catheter that delivers a circumferential ring of ablative ultrasound energy
DEVICE	Catheter ablation	Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation

Timeline

• Start date: 2020-07-08
• Primary completion: 2025-02-26
• Completion: 2025-02-26
• First posted: 2019-12-02
• Last updated: 2025-05-08

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study