Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation

Atrial Fibrillation Clinical Trial

Official title:

Pulsed Field Ablation Under Mild Conscious Sedation - A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014814
• Other study ID #: PFA-Sedation-Study
• Secondary ID: IRAS
• Status: Recruiting
• Start date: August 21, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Contact: Peter Calvert, MBChB
• Phone: 01516001616
• Email: peter.calvert[@]lhch.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective case-control study comparing pulsed field ablation for atrial fibrillation under mild conscious sedation vs standard of care (general anaesthesia).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients clinically referred for and undergoing catheter ablation of atrial fibrillation using pulsed field ablation

Exclusion Criteria:

• Inability to provide informed consent

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation
Catheter ablation of atrial fibrillation

Locations

Country	Name	City	State
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient experience (Pain; Relative)	5 point Likert scale for pain during the procedure, 1 = much worse than expected, 5 = much better than expected	Intraprocedural
Secondary	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
Secondary	Patient experience (Anxiety; Relative)	5 point Likert scale for anxiety during the procedure, 1 = much worse than expected, 5 = much better than expected	Intraprocedural
Secondary	Patient experience (Pain; Absolute)	Visual analogue score for pain during the procedure (1-100, 1 = none, 100 = worst imaginable)	Intraprocedural
Secondary	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
Secondary	Patient experience (Anxiety; Absolute)	Visual analogue score anxiety during the procedure (1-100, 1 = none, 100 = worst imaginable)	Intraprocedural
Secondary	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
Secondary	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
Secondary	Acute procedural success	Were all pulmonary veins isolated at procedure end?	Immediately after the procedure
Secondary	Procedure Duration	Skin-to-skin time - i.e. from first needle insertion to withdrawal of sheaths	During procedure
Secondary	Fluoroscopy Duration	Time spent with x-ray active	During procedure
Secondary	Left atrial dwell time	Time spent with catheters inside the left atrium	During procedure
Secondary	Ablation Duration	Time from first ablation application to end of final ablation application	During procedure
Secondary	Sedative and anaesthetic drug doses	Doses of sedatives, analgesics and anaesthetics administered during the procedure	During procedure
Secondary	Acute Procedural Complications	Whether any complications occurred	Immediately after the procedure
Secondary	Same-day discharge rates	How many patients per arm went home on the same day as their procedure	24 hours