Prospective case-control study comparing pulsed field ablation for atrial fibrillation under mild conscious sedation vs standard of care (general anaesthesia).
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
40
Catheter ablation of atrial fibrillation
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Number and Percentage of Patients Converting to General Anaesthesia in the Conscious Sedation Arm
Requirement for conversion to general anaesthesia from mild conscious sedation
Time frame: Intraprocedural
Patient experience (Pain; Relative)
5 point Likert scale for pain during the procedure, 1 = much worse than expected, 5 = much better than expected
Time frame: 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
Time frame: Intraprocedural
Patient experience (Anxiety; Relative)
5 point Likert scale for anxiety during the procedure, 1 = much worse than expected, 5 = much better than expected
Time frame: Intraprocedural
Patient experience (Pain; Absolute)
Visual analogue score for pain during the procedure; 1-100, 1 = none, 100 = worst imaginable
Time frame: 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)
Time frame: Intraprocedural
Patient experience (Anxiety; Absolute)
Visual analogue score anxiety during the procedure; 1-100, 1 = none, 100 = worst imaginable
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Time frame: 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)
Time frame: 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)
Time frame: Immediately after the procedure
Acute procedural success
Were all pulmonary veins isolated at procedure end?
Time frame: Immediately after the procedure
Procedure Duration
Skin-to-skin time - i.e. from first needle insertion to withdrawal of sheaths
Time frame: During procedure
Fluoroscopy Duration
Time spent with x-ray active
Time frame: During procedure
Left atrial dwell time
Time spent with catheters inside the left atrium
Time frame: During procedure
Ablation Duration
Time from first ablation application to end of final ablation application
Time frame: During procedure
Sedative and anaesthetic drug doses
Doses of sedatives, analgesics and anaesthetics administered during the procedure
Time frame: During procedure
Acute Procedural Complications
Whether any complications occurred
Time frame: Immediately after the procedure
Same-day discharge rates
How many patients per arm went home on the same day as their procedure
Time frame: 24 hours