Conscious Sedation vs General Anesthesia in PFA for Paroxysmal A-Fib
ClinicalTrials.gov Studies
Summary
A clinical trial comparing conscious sedation and general anesthesia in patients undergoing pulsed-field ablation for paroxysmal atrial fibrillation has been registered on ClinicalTrials.gov. The randomized controlled study will assign participants at a 1:1 ratio and monitor for composite safety endpoints including persistent hypotension or hypoxemia exceeding 60 seconds intraoperatively. Follow-up assessments are scheduled at 12-24 hours, 30 days, and 90 days post-procedure.
“Researchers will randomly assign eligible patients to a conscious sedation group or a general anesthesia group at a 1:1 ratio to compare the safety and efficacy of the two anesthetic approaches.”
What changed
A new clinical trial (NCT07541339) has been registered on ClinicalTrials.gov, evaluating two anesthetic strategies for pulsed-field ablation in paroxysmal atrial fibrillation patients. The study will track safety endpoints and adverse events across both groups with defined follow-up windows. Trial sponsors and clinical investigators should ensure compliance with applicable Good Clinical Practice requirements and FDA IND obligations if applicable.
For healthcare providers and clinical research institutions, this registry entry signals ongoing investigation into anesthetic protocol optimization for cardiac ablation procedures. Sites considering PFA programs may wish to monitor findings from this head-to-head comparison.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
N/A NCT07541339 Kind: NA Apr 21, 2026
Abstract
The goal of this clinical trial is to compare the safety and efficacy of conscious sedation and general anesthesia in patients with paroxysmal atrial fibrillation undergoing their first pulsed-field ablation (PFA) procedure. It will also establish a scalable conscious sedation protocol for PFA. The main questions it aims to answer are:
- Does conscious sedation reduce the incidence of the composite safety endpoint (persistent hypotension or hypoxemia for more than 60 seconds intraoperatively) compared with general anesthesia?
- What are the differences in perioperative indicators and adverse events between the two anesthetic strategies in PFA for paroxysmal atrial fibrillation? Researchers will randomly assign eligible patients to a conscious sedation group or a general anesthesia group at a 1:1 ratio to compare the safety and efficacy of the two anesthetic approaches.
Participants will:
- Receive the assigned anesthetic strategy combined with standardized PFA procedure
- Complete intraoperative vital sign and related index monitoring
- Undergo follow-up visits at 12-24 hours, 30 days and 90 days after surgery for relevant index assessment and adverse event recording
Conditions: Atrial Fibrillation (Paroxysmal)
Interventions: conscious sedation, General Anesthesia (control group)
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