Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation

Last updated: October 31, 2024
Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Overall Status: Completed

Phase

N/A

Condition

Cardiac Disease

Atrial Fibrillation

Chest Pain

Treatment

Catheter ablation

Clinical Study ID

NCT06014814
PFA-Sedation-Study
IRAS
  • Ages > 18
  • All Genders

Study Summary

Prospective case-control study comparing pulsed field ablation for atrial fibrillation under mild conscious sedation vs standard of care (general anaesthesia).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients clinically referred for and undergoing catheter ablation of atrialfibrillation using pulsed field ablation

Exclusion

Exclusion Criteria:

  • Inability to provide informed consent

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Catheter ablation
Phase:
Study Start date:
August 21, 2023
Estimated Completion Date:
June 11, 2024

Study Description

This study will prospectively assess 40 patients (20 per arm). Those in the general anaesthesia arm will undergo routine clinical practice. Those in the mild conscious sedation arm will undergo pulsed field ablation with intravenous sedation but without general anaesthesia, though conversion to general anaesthesia is allowed if the patient does not tolerate the procedure.

Connect with a study center

  • Liverpool Heart and Chest Hospital

    Liverpool,
    United Kingdom

    Site Not Available

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