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Renal Denervation + PVI vs PVI Alone for Persistent AF

Study acronym: ERADICATE-AF
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Jun 30, 2026 → Jul 31, 2027
See other at-risk trials from University of Rochester

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 30, 2026 to Jul 31, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 10 entries
    • Publications: details revised at 1 of 1 entry
    • Study description shortened, about 4 words
  2. Publications: details revised at 1 of 1 entryv16
  3. Primary and study completion dates: Mar 31, 2025 to Jun 30, 2026
    • Site contact updated
    • Publications: details revised at 1 of 1 entry
    v15
  4. Re-verified, no change to tracked fieldsv14
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Start date: Jun 12, 2023 to Jul 30, 2023v12
  2. Start date: May 1, 2023 to Jun 12, 2023v11
  3. Lead sponsor: [Redacted] to University of Rochesterv10 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary and study completion dates: Mar 31, 2025
    • Start date: May 1, 2023
    • Collaborators expanded, about 7 words
    • Study title shortened, about 3 words
  4. 8 versions Re-verified since Dec 8, 2021, no change to tracked fieldsv2-v9
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05116384
Lead Sponsor University of Rochester
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Atrial Fibrillation
Related terms Atrial Fibrillation
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov