Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation

Pulsed Field Ablation Under Mild Conscious Sedation - A Feasibility Study

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter ablation

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been referred clinically for ablation of atrial fibrillation, and will be undergoing this procedure using pulsed field ablation. Patients will not be randomised in this feasibility study - the decision to perform the procedure under mild conscious sedation will be made between the consultant and the patient.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute procedural success	Were all pulmonary veins isolated at procedure end?	Immediately after the procedure
Procedure Duration	Skin-to-skin time - i.e. from first needle insertion to withdrawal of sheaths	During procedure
Fluoroscopy Duration	Time spent with x-ray active	During procedure
Left atrial dwell time	Time spent with catheters inside the left atrium	During procedure
Ablation Duration	Time from first ablation application to end of final ablation application	During procedure
Sedative and anaesthetic drug doses	Doses of sedatives, analgesics and anaesthetics administered during the procedure	During procedure
Acute Procedural Complications	Whether any complications occurred	Immediately after the procedure
Same-day discharge rates	How many patients per arm went home on the same day as their procedure	24 hours
Patient experience (Pain; Relative)	5 point Likert scale for pain during the procedure, 1 = much worse than expected, 5 = much better than expected	Intraprocedural
Patient experience (Discomfort; Relative)	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	Intraprocedural
Patient experience (Anxiety; Relative)	5 point Likert scale for anxiety during the procedure, 1 = much worse than expected, 5 = much better than expected	Intraprocedural
Patient experience (Discomfort; Absolute)	Visual analogue score for discomfort (for example thumping, heart racing, muscle twitching) during the procedure (1-100, 1 = none, 100 = worst imaginable)	Intraprocedural
Post-operative discomfort (Visual analogue score)	Visual analogue scores for sites post-operative discomfort (groin, chest, throat), (1-100, 1 = none, 100 = worst imaginable)	Immediately after the procedure
Friends and family test	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)	Immediately after the procedure
Patient experience (Pain; Absolute)	Visual analogue score for pain during the procedure; 1-100, 1 = none, 100 = worst imaginable	Intraprocedural
Patient experience (Anxiety; Absolute)	Visual analogue score anxiety during the procedure; 1-100, 1 = none, 100 = worst imaginable	Intraprocedural

Collaborators and Investigators

• Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Investigators: Study Chair: Dhiraj Gupta, MD, Liverpool Heart & Chest Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Actual): June 11, 2024
• Study Completion (Actual): June 11, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PFA-Sedation-Study; IRAS (Other Identifier: 348528)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymised dataset can be made available upon reasonable request. Identifiable data will not be made available for confidentiality reasons.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No