Actively Recruiting
Renal Denervation + PVI vs PVI Alone for Persistent AF
Led by University of Rochester · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Renal Denervation + PVI vs PVI Alone for Persistent AF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Diagnosed with symptomatic persistent atrial fibrillation lasting more than 7 days and up to 1 year
- No history of hypertension or hypertension controlled with medication (blood pressure below 140/85 mm Hg)
- Renal arteries accessible as shown by pre-procedure renal magnetic resonance angiogram
- Agree to have an implantable loop recorder placed
- Willing to comply with follow-up visits and sign informed consent
You will not qualify if you...
- Unable to undergo atrial fibrillation catheter ablation (e.g., left atrial clot, contraindication to blood thinners)
- Previous left atrial ablation for arrhythmia
- Severe heart failure (NYHA class IV) or left ventricular ejection fraction below 25%
- Paroxysmal atrial fibrillation or atrial fibrillation lasting longer than 1 year
- Coronary artery procedures or valve surgery within past 3 months
- Previous valve surgery with a mechanical prosthesis
- Renal artery issues making treatment impossible, including small arteries, multiple main arteries, prior artery interventions, or significant abnormalities
- Estimated kidney function (eGFR) below 45 mL/min/1.73m2
- Life expectancy less than 1 year due to any medical condition
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Rochester
Short Hills, New Jersey, United States, 07078
Actively Recruiting
Research Team
J
Jonathan Steinberg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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