Renal Denervation + PVI vs PVI Alone for Persistent AF
Recruiting · NCT05116384 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Rochester
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 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
- Multiple main renal arteries to either kidney
- An estimated glomerular filtration rate (eGFR) \< 45mL/min/1.73m2, using the MDRD calculation
- Life expectancy \<1 year for any medical condition
Where it is running
1 location listed across 1 US state.
- University of Rochester - Short Hills, New Jersey, United States