A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
University of Rochester
RECRUITING
Short Hills
Contact Information
Primary
Jonathan Steinberg, MD
jsteinberg@smgnj.com
9734364155
Time Frame
Start Date: 2023-07-30
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 50
Treatments
Active_comparator: Pulmonary vein isolation
Electrical isolation by cryoballoon of all pulmonary veins
Experimental: Pulmonary vein isolation + renal artery denervation
After completion of the standard PVI, radiofrequency ablation of bilateral renal arteries
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Rochester

This content was sourced from clinicaltrials.gov