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ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
Sponsor: Vivek Reddy
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).
Official title: Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation - Redo Ablation Procedures: A Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2023-12-07
Completion Date
2027-12
Last Updated
2025-12-15
Healthy Volunteers
No
Interventions
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
Catheter Ablation
Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation.
Locations (8)
Arrhythmia Research Group
Jonesboro, Arkansas, United States
UCSF
San Francisco, California, United States
Los Robles Medical Center
Thousand Oaks, California, United States
Henry Ford Health System
Detroit, Michigan, United States
Mount Sinai Hospital
New York, New York, United States
Trident Medical Center
Charleston, South Carolina, United States
Christus
Tyler, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States