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The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Dec 31, 2026 → Mar 31, 2027
See other at-risk trials from Wroclaw Medical University

Record History

  1. Enrollment closed, study ongoing
    • Primary and study completion pushed from Dec 31, 2026 to Mar 31, 2027
    • Site details revised
    v4
  2. Primary and study completion dates: Jun 30, 2026 to Dec 31, 2026v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2024 to May 10, 2024
    • Study sites: 0 to 1
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.
Trial Details
NCT Number NCT06053606
Lead Sponsor Wroclaw Medical University
Collaborators: Boston Scientific Corporation
Conditions
(from sponsor)		 Paroxysmal Atrial Fibrillation
Related terms Atrial Fibrillation
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov