ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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).
Sponsor: Vivek Reddy
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%
Where it's recruiting
Jonesboro
San Francisco · Thousand Oaks
Detroit
New York
Charleston
Tyler
Richmond
Source: ClinicalTrials.gov · NCT05988411 · last updated 2025-12-15