Kidney Nerve Procedure Added to Heart Ablation for Persistent Atrial Fibrillation
Tests a kidney nerve procedure added to heart ablation in adults with persistent atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Renal Denervation + PVI vs PVI Alone for Persistent AF
Key facts
- Where
- Short Hills, United StatesSee the site
Where in United States
- University of RochesterShort Hills, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Rochester
- Trial code
- NCT05116384
- Record updated
- 13 October 2026
- Original description
Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation (AF). Increased cardiac sympathetic stimulation can facilitate AF and reduction can be accomplished by renal artery denervation (RDN). The recently completed randomized trial, ERADICATE-AF, convincingly demonstrated that RDN plus PVI resulted in a reduction in recurrent incident AF for uncontrolled hypertensives.Read full original descriptionShow less
A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation
Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation (AF). Increased cardiac sympathetic stimulation can facilitate AF and reduction can be accomplished by renal artery denervation (RDN). The recently completed randomized trial, ERADICATE-AF, convincingly demonstrated that RDN plus PVI resulted in a reduction in recurrent incident AF for uncontrolled hypertensives.
This is a randomized controlled pilot trial, "To Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation" (ERADICATE-AF II) to test if RDN plus PVI enhances long-term efficacy vs PVI for persistent AF patients with controlled or without hypertension using implantable loop recordings.
Inclusion: Age > 18 years; Symptomatic persistent AF eligible for referral for PVI based on current guidelines1 (persistent AF defined as continuation > 7 days and up to 1 year); No prior history of HTN or HTN controlled on medical therapy (defined as SBP <140 mm Hg and DBP <85 mm Hg); Renal vasculature accessible as determined by pre-procedural renal magnetic resonance angiogram; Willingness to undergo ILR placement; Willingness to comply with post-procedural follow-up requirements and to sign informed consent.
Exclusion: Prior left atrial ablation for an atrial arrhythmia; Coronary revascularization or valve surgery within 3 months; Prior valve surgery using a mechanical prosthesis; Renal artery anatomy that is ineligible for treatment including:; Predicted inability to access renal vasculature; Main renal arteries < 4 mm in diameter or < 20 mm in length; Hemodynamically or anatomically significant renal artery abnormality or stenosis; A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment; Multiple main renal arteries to either kidney; Life expectancy <1 year for any medical condition; NYHA class IV congestive heart failure or LVEF < 25%; An estimated glomerular filtration rate (eGFR) < 45mL/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); Paroxysmal AF, or longstanding persistent AF (duration > 1 year).