Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation

Study Overview
=================
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.

Official Title
-----------------
Pulsed Field Ablation Under Mild Conscious Sedation - A Feasibility Study

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Catheter ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients clinically referred for and undergoing catheter ablation of atrial fibrillation using pulsed field ablation Exclusion Criteria: Inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulsed Field Ablation - General Anaesthesia<br>Patients undergoing pulsed field ablation for atrial fibrillation under general anaesthetic. | Procedure: Catheter ablation<br>* Catheter ablation of atrial fibrillation<br>|
| Pulsed Field Ablation - Mild Conscious Sedation<br>Patients undergoing pulsed field ablation for atrial fibrillation under mild conscious sedation. | Procedure: Catheter ablation<br>* Catheter ablation of atrial fibrillation<br>|

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 |
| --- | --- | --- |
| 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 (Pain; Absolute) | Visual analogue score for pain during the procedure (1-100, 1 = none, 100 = worst imaginable) | 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 | 
| Patient experience (Anxiety; Absolute) | Visual analogue score anxiety 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 | 
| 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 |