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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
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 - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation.
Arrhythmia Research Group
Jonesboro, Arkansas, United States
RECRUITINGUCSF
San Francisco, California, United States
RECRUITINGLos Robles Medical Center
Thousand Oaks, California, United States
RECRUITINGHenry Ford Health System
Detroit, Michigan, United States
RECRUITINGMount Sinai Hospital
New York, New York, United States
RECRUITINGTrident Medical Center
Charleston, South Carolina, United States
RECRUITINGChristus
Tyler, Texas, United States
RECRUITINGVirginia Commonwealth University
Richmond, Virginia, United States
RECRUITINGFreedom from atrial arrhythmias with no AADs
Freedom from atrial arrhythmias (AT/AF/AFL) recurrence ≥ 30 seconds off all antiarrhythmic drug uses (AADs) (after the 90-day blanking period).
Time frame: after 90 days
Freedom from atrial arrhythmias (AT/AF/AFL) with AADs
Freedom from AT/AF/AFL recurrence ≥ 30 seconds at 12 months (not including a 3-month blanking period) despite taking AADs
Time frame: at 12 months
Procedure-related adverse events
Number of procedure-related adverse events
Time frame: at 12 months
Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)
Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT). Each item scored from 1-7, with total scale from 20-140, Lower score indicates better health outcomes.
Time frame: at 12 months
Blood pressure
Blood pressure - Systolic and Diastolic
Time frame: at 12 months
Number of AF episodes
AF burden assessed by the amount of AF episodes detected during Event Monitoring
Time frame: at 12 months
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