Actively Recruiting
ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
Led by Vivek Reddy · Updated on 2025-12-15
250
Participants Needed
8
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for a redo atrial fibrillation ablation procedure for paroxysmal or persistent AF
- Prior successful AF ablation procedure with pulmonary vein isolation and bidirectional block of any attempted anatomic lesion sets
- Clinical recurrences primarily atrial fibrillation, not atrial flutter or tachycardia
- History of hypertension with either documented high blood pressure (SBP60 or DBP100) or on at least one antihypertensive medication
- Willingness to follow study restrictions and attend all follow-up visits
You will not qualify if you...
- Long-standing persistent AF over 12 months or more than 3 prior AF ablations
- AF ablation within 3 months before enrollment or extensive left atrium scarring
- Valvular AF or AF caused by a reversible condition
- Prior treatment with other hypertension devices like ROX Coupler or CVRx barostimulator
- Severe heart failure (NYHA class IV)
- Renal artery anatomy ineligible for treatment, including artery diameter less than 3 mm or more than 8 mm, artery length less than 20 mm, stenosis 30% or greater, calcification, aneurysm, tumors, stents, or fibromuscular disease
- Estimated glomerular filtration rate under 40 mL/min/1.73m2
- Unable to undergo AF catheter ablation (e.g., left atrial thrombus, anticoagulation contraindication)
- Known allergy to contrast medium not treatable
- Life expectancy less than 1 year
- Recent heart attack, unstable angina, stroke, or heart failure admission within 3 months
- Chronic active inflammatory bowel disease such as Crohn's or ulcerative colitis
- Pregnant or nursing females
- Known secondary hypertension
- Single functioning kidney
- History of drug or alcohol dependency or inability to comply with study
- Participation in other investigational drug or device trials that interfere with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
UCSF
San Francisco, California, United States, 94143
Actively Recruiting
3
Los Robles Medical Center
Thousand Oaks, California, United States, 91360
Actively Recruiting
4
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
5
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
6
Trident Medical Center
Charleston, South Carolina, United States, 29406
Actively Recruiting
7
Christus
Tyler, Texas, United States, 75702
Actively Recruiting
8
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
J
Jeff Lam, MS
CONTACT
B
Betsy Ellsworth, MSN ANP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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