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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Renal denervation using the Paradise renal denervation system - a dedicated 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
University of Arizona - Banner University Medical Center
Phoenix, Arizona, United States
Arizona Heart Institute
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds
Single-procedure freedom from AT/AF/AFL recurrence ≥ 30 seconds off Class I and III AADs (after the 90-day blanking period), defined by absence of any electrocardiographically documented AT/AF.
Time frame: 12 months
Freedom from AT/AF/AFL recurrence
Freedom from AT/AF/AFL recurrence through 12 months (excluding a 90-day blanking period from the initial ablation procedure) irrespective of AADs
Time frame: 12 months
Rate of procedural adverse events
Rate of procedural adverse events
Time frame: 30 days
The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire
Quality of life instrument (AFEQT) is a 20-item disease-specific scale developed to capture subjective ratings of AF disease and treatment burden. Full range score from 0-100, with higher score indicating higher level of quality of life.
Time frame: 12 months
Change in office systolic blood pressure change from baseline to 12 months
Change in office systolic blood pressure change from baseline to 12 months
Time frame: 12 months
AF burden at 6 months
AF burden at 6 months
Time frame: 6 months
AF burden at 12 months
AF burden at 12 months
Time frame: 12 months
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Loma Linda University Medical
Loma Linda, California, United States
Pacific Heart Institute
Santa Monica, California, United States
Hartford Healthcare
Hartford, Connecticut, United States
Naples Community Hospital
Naples, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mount Sinai Hospital
New York, New York, United States
...and 3 more locations