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| ID | Type | Description | Link |
|---|---|---|---|
| IRAS | Other Identifier | 320883 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Field Ablation - General Anaesthesia | Patients undergoing pulsed field ablation for atrial fibrillation under general anaesthetic. |
| |
| Pulsed Field Ablation - Mild Conscious Sedation | Patients undergoing pulsed field ablation for atrial fibrillation under mild conscious sedation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation | Procedure | Catheter ablation of atrial fibrillation |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Heart and Chest Hospital | Liverpool | United Kingdom |
Anonymised dataset can be made available upon reasonable request. Identifiable data will not be made available for confidentiality reasons.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |