Renal Denervation + PVI vs PVI Alone for Persistent AF
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
catheter ablation
Devicecryo energy via cryoballoon
renal artery denervation
DeviceRF energy delivery to multiple sites within each major renal artery
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Pulmonary vein isolationActive comparator 1 intervention
Group B: Pulmonary vein isolation + renal artery denervationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
AF burden
The calculated total amount of time in AF after 3-month blanking period
Time frame
At 1 yearSecondary outcomes
1
Procedural complications, radiation exposure, and duration
Adverse events
Time frame
30 days and 12 months2
BP changes over time
Orthostatic BP measurements
Time frame
At 0, 1, 3, 6 and 12 months3
BP changes over time
Ambulatory BP monitoring
Time frame
6 months vs baseline4
Cardiac sympathetic nervous system modulation
Heart rate variability
Time frame
At 0, 1, 3, 6 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rochester
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov