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

Running, not enrolling · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT05988411

Run by

Vivek Reddy

People needed

143

Starts

2023-12-07

Expected to finish

2027-12-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18;
• Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as successful pulmonary vein isolation, if needed, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation, must have been completed). Note: the clinical recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the dominant recurrent rhythm.)
• History of hypertension and either:
• Documented history of SBP≥160 or DBP≥100, or;
• Receiving ≥1 antihypertensive medication;
• Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements

You may not qualify if…

• Long-standing persistent AF (>12 months); >3 prior atrial fibrillation ablations (lifetime); AF ablation within 3 months of enrollment; extensive scar in left atrium.
• Individual with valvular AF or AF due to a reversible cause
• Prior treatment with other devices for hypertension including but not limited to ROX Coupler, Mobius stent, and/or the CVRx barostimulator device.
• NYHA class IV congestive heart failure;
• Individual has renal artery anatomy that is ineligible for treatment (as determined by renal angiography);
• Main renal artery diameter <3mm or >8.0 mm
• Main renal treatable artery length < 20 mm (length may include proximal branches)
• Presence of renal artery stenosis of any origin ≥30%
• Calcification in renal arteries
• Prior renal denervation procedure
• Presence of abnormal kidney tumors
• Renal artery aneurysm
• Pre-existing renal stent or history of renal artery angioplasty
• Pre-existing aortic stent or history of aortic aneurysm
• Fibromuscular disease of the renal arteries
• Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
• Individual has an estimated glomerular filtration rate (eGFR) of less than 40mL/min/1.73m2, using the MDRD calculation;
• Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
• Individual with known allergy to contrast medium not amendable to treatment.
• Life expectancy <1 year for any medical condition
• Individual has experienced a myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit.
• Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis.
• Female participants who are pregnant or nursing.
• Individual has known secondary hypertension.
• Individual has a single functioning kidney (either congenitally or iatrogenically).

Where it is running

• 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

Full record on ClinicalTrials.gov

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