Clinical trial NCT06014814: Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation
Official title: Pulsed Field Ablation Under Mild Conscious Sedation - A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Number and Percentage of Patients Converting to General Anaesthesia in the Conscious Sedation Arm
timeFrame: Intraprocedural
Secondary outcomes:
measure: Patient experience (Pain; Relative)
timeFrame: Intraprocedural
measure: Patient experience (Discomfort; Relative)
timeFrame: Intraprocedural
measure: Patient experience (Anxiety; Relative)
timeFrame: Intraprocedural
measure: Patient experience (Pain; Absolute)
timeFrame: Intraprocedural
measure: Patient experience (Discomfort; Absolute)
timeFrame: Intraprocedural
measure: Patient experience (Anxiety; Absolute)
timeFrame: Intraprocedural
measure: Post-operative discomfort (Visual analogue score)
timeFrame: Immediately after the procedure
measure: Friends and family test
timeFrame: Immediately after the procedure
measure: Acute procedural success
timeFrame: Immediately after the procedure
measure: Procedure Duration
timeFrame: During procedure
measure: Fluoroscopy Duration
timeFrame: During procedure
measure: Left atrial dwell time
timeFrame: During procedure
measure: Ablation Duration
timeFrame: During procedure
measure: Sedative and anaesthetic drug doses
timeFrame: During procedure
measure: Acute Procedural Complications
timeFrame: Immediately after the procedure
measure: Same-day discharge rates
timeFrame: 24 hours
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
Study officials:
References: