Atrial Fibrillation
Conditions
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.
Interventions
PROCEDURECatheter ablation
Catheter ablation of atrial fibrillation
Sponsors
Liverpool Heart and Chest Hospital NHS Foundation Trust
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients clinically referred for and undergoing catheter ablation of atrial fibrillation using pulsed field ablation
Exclusion criteria
* Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Patient experience (Pain; Relative) | Intraprocedural | 5 point Likert scale for pain during the procedure, 1 = much worse than expected, 5 = much better than expected |
| Procedure Duration | During procedure | Skin-to-skin time - i.e. from first needle insertion to withdrawal of sheaths |
| Fluoroscopy Duration | During procedure | Time spent with x-ray active |
| Left atrial dwell time | During procedure | Time spent with catheters inside the left atrium |
| 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 |
| Acute procedural success | Immediately after the procedure | Were all pulmonary veins isolated at procedure end? |
Countries
United Kingdom
Outcome results
None listed