Renal Denervation + PVI vs PVI Alone for Persistent AF (NCT05116384)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (15 items).
Location: University of Rochester — Short Hills, New Jersey
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
- Prior left atrial ablation for an atrial arrhythmia
- NYHA class IV congestive heart failure or LVEF \< 25%
- Paroxysmal AF, or longstanding persistent AF (duration \> 1 year)
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Rochester — Short Hills, New Jersey
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.