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Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation

L

Liverpool Heart and Chest Hospital NHS Foundation Trust

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Procedure: Catheter ablation

Study type

Observational

Funder types

Other

Identifiers

NCT06014814
IRAS (Other Identifier)
PFA-Sedation-Study

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Inability to provide informed consent

Trial design

40 participants in 2 patient groups

Pulsed Field Ablation - General Anaesthesia
Description:
Patients undergoing pulsed field ablation for atrial fibrillation under general anaesthetic.
Treatment:
Procedure: Catheter ablation
Pulsed Field Ablation - Mild Conscious Sedation
Description:
Patients undergoing pulsed field ablation for atrial fibrillation under mild conscious sedation.
Treatment:
Procedure: Catheter ablation

Trial contacts and locations

1

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Central trial contact

Dhiraj Gupta, MD; Peter Calvert, MBChB

Data sourced from clinicaltrials.gov

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