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Prospective Evaluation of Biophysical Parameters as Long-term Predictors of Pulmonary Vein Isolation

Study acronym: MERCY
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Jun 2025 to Sep 30, 2025 · Completion date: Jun 2025 to Sep 30, 2026 · Site details revisedv5 Show 3 more changesShow less
    • Primary completion date changed from estimate of Jun 2025 to Sep 30, 2025
    • Completion date: Jun 2025 to Sep 30, 2026
    • Site details revised
  2. 3 versions Re-verified since Feb 16, 2024, no change to tracked fieldsv2-v4
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Current, worldwide assessments of the prevalence of AF estimate that 33 million people are affected by this cardiac arrhythmia. As the most common sustained atrial arrhythmia, AF has a well-established association with systemic embolic events, stroke, heart failure, and increased mortality. Current treatment guidelines and consensus statements for patients with AF suggest that most patients should be first managed with a pharmaceutical drug therapy; however, when a patient becomes drug refractory (intolerant or non-responsive), catheter ablation by PV isolation (PVI) is recommended. The aim of PVI is abolishment of all conducted electrical activity beyond the isolating lesions. The recent NICE guidelines have established that today RF point-by-point ablation is the most cost-effective treatment approach over a lifetime after failure of 1 or more anti-arrhythmic drugs5, but until now a new technology, HELIOSTAR, RF Balloon, has not been included in this cost-effectiveness analysis
Trial Details
NCT Number NCT05805189
Lead Sponsor Maria Cecilia Hospital
Conditions Atrial Fibrillation
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov