Renal Denervation + PVI vs PVI Alone for Persistent AF

Part of paid clinical trials in Short Hills, New Jersey.

Sponsor
University of Rochester
Study ID
NCT05116384
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • catheter ablation — DEVICE
    cryo energy via cryoballoon
  • renal artery denervation — DEVICE
    RF energy delivery to multiple sites within each major renal artery

Study Details

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.

Key Dates

Start date
Jul 30, 2023
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

AF burden [ Time Frame: At 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterShort HillsNew Jersey07078
Jonathan Steinberg
[email protected]
9734364155

Find similar trials in Short Hills, NJ

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
University of Rochester· Short Hills, NJ

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