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RECRUITING
NCT05988411
NA

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

Sponsor: Vivek Reddy

View on ClinicalTrials.gov

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

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.

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