NCT05988411

ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Vivek Reddy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is a prospective, controlled, single-blind, randomized trial. The pilot study will be conducted in up to 20 clinical sites in the United States. Once the clinical sites are up and running (expected to take 6 months), accrual is expected to take an additional 9 months, and all patients will be followed for 12 months post randomization. Patients, the Clinical Events Committee and the ECG core lab will be blinded during the trial. Patients will be unblinded at the 12-month visit.

Conditions

• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Renal Denervation	Renal denervation using the Paradise renal denervation system - a dedicated Renal Denervation (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: 2023-12-07
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2023-08-14
• Last updated: 2025-12-15

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study