A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation
University of Rochester
Summary
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.
Description
Pulmonary vein isolation (PVI) is the cornerstone of ablation strategies for atrial fibrillation (AF) and is the only cardio-centric approach consistently shown to be effective for reducing arrhythmia recurrence and improving symptom status. Catheter ablation is superior to medical therapy and current antiarrhythmic drug options are limited, can have significant adverse effects, and are associated with a high arrhythmia recurrence rate, especially for persistent AF. Catheter ablation is now commonly prescribed for symptomatic AF patients who do not respond to medications and carries a class II…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age \> 18 years 2. Symptomatic persistent AF eligible for referral for PVI based on current guidelines1 (persistent AF defined as continuation \> 7 days and up to 1 year) 3. No prior history of HTN or HTN controlled on medical therapy (defined as SBP \<140 mm Hg and DBP \<85 mm Hg) 4. Renal vasculature accessible as determined by pre-procedural renal magnetic resonance angiogram 5. Willingness to undergo ILR placement 6. Willingness to comply with post-procedural follow-up requirements and to sign informed consent. Exclusion Criteria: 1. Inability to undergo AF cathet…
Interventions
- Devicecatheter ablation
cryo energy via cryoballoon
- Devicerenal artery denervation
RF energy delivery to multiple sites within each major renal artery
Location
- University of RochesterShort Hills, New Jersey