Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Catheter ablation

• Registration Number: NCT06014814
• Lead Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-07-17
• Study Start: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-28
• Primary Completion: 2024-06-11
• Study Completion: 2024-06-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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Exclusion Criteria

• Inability to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number and Percentage of Patients Converting to General Anaesthesia in the Conscious Sedation Arm	Intraprocedural	Requirement for conversion to general anaesthesia from mild conscious sedation

Secondary Outcome Measures

Name	Time	Method
Patient experience (Pain; Relative)	Intraprocedural	5 point Likert scale for pain during the procedure, 1 = much worse than expected, 5 = much better than expected
Patient experience (Discomfort; Relative)	Intraprocedural	5 point Likert scale for discomfort (for example, thumping, heart racing, muscle twitching) during the procedure, 1 = much worse than expected, 5 = much better than expected
Patient experience (Anxiety; Relative)	Intraprocedural	5 point Likert scale for anxiety during the procedure, 1 = much worse than expected, 5 = much better than expected
Patient experience (Pain; Absolute)	Intraprocedural	Visual analogue score for pain during the procedure; 1-100, 1 = none, 100 = worst imaginable
Patient experience (Discomfort; Absolute)	Intraprocedural	Visual analogue score for discomfort (for example thumping, heart racing, muscle twitching) during the procedure (1-100, 1 = none, 100 = worst imaginable)
Patient experience (Anxiety; Absolute)	Intraprocedural	Visual analogue score anxiety during the procedure; 1-100, 1 = none, 100 = worst imaginable
Post-operative discomfort (Visual analogue score)	Immediately after the procedure	Visual analogue scores for sites post-operative discomfort (groin, chest, throat), (1-100, 1 = none, 100 = worst imaginable)
Friends and family test	Immediately after the procedure	Would the patient recommend the procedure to a friend or family member with the same condition? (5 point Likert scale, 1 = definitely not, 5 = definitely)
Acute procedural success	Immediately after the procedure	Were all pulmonary veins isolated at procedure end?
Procedure Duration	During procedure	Skin-to-skin time - i.e. from first needle insertion to withdrawal of sheaths
Left atrial dwell time	During procedure	Time spent with catheters inside the left atrium
Fluoroscopy Duration	During procedure	Time spent with x-ray active
Ablation Duration	During procedure	Time from first ablation application to end of final ablation application
Sedative and anaesthetic drug doses	During procedure	Doses of sedatives, analgesics and anaesthetics administered during the procedure
Acute Procedural Complications	Immediately after the procedure	Whether any complications occurred
Same-day discharge rates	24 hours	How many patients per arm went home on the same day as their procedure

Trial Locations

Locations (1)

Liverpool Heart and Chest Hospital; 🇬🇧 Liverpool, United Kingdom