Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation

• Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06014814
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 4.3
• Patients Per Site Per Month: 9.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Catheter ablation

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Pulsed Field Ablation Under Mild Conscious Sedation - A Feasibility Study
• Actual Study Start Date: Aug 21, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Pulsed Field Ablation - General Anaesthesia Patients undergoing pulsed field ablation for atrial fibrillation under general anaesthetic.	Procedure: Catheter ablation; Catheter ablation of atrial fibrillation
Pulsed Field Ablation - Mild Conscious Sedation Patients undergoing pulsed field ablation for atrial fibrillation under mild conscious sedation.	Procedure: Catheter ablation; Catheter ablation of atrial fibrillation

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Patient experience (Pain; Relative) [Intraprocedural]

   5 point Likert scale for pain during the procedure, 1 = much worse than expected, 5 = much better than expected

2. 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

3. Patient experience (Anxiety; Relative) [Intraprocedural]

   5 point Likert scale for anxiety during the procedure, 1 = much worse than expected, 5 = much better than expected

4. Patient experience (Pain; Absolute) [Intraprocedural]

   Visual analogue score for pain during the procedure (1-100, 1 = none, 100 = worst imaginable)

5. 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)

6. Patient experience (Anxiety; Absolute) [Intraprocedural]

   Visual analogue score anxiety during the procedure (1-100, 1 = none, 100 = worst imaginable)

7. 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)

8. 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)

9. Acute procedural success [Immediately after the procedure]

   Were all pulmonary veins isolated at procedure end?

10. Procedure Duration [During procedure]

    Skin-to-skin time - i.e. from first needle insertion to withdrawal of sheaths

11. Fluoroscopy Duration [During procedure]

    Time spent with x-ray active

12. Left atrial dwell time [During procedure]

    Time spent with catheters inside the left atrium

13. Ablation Duration [During procedure]

    Time from first ablation application to end of final ablation application

14. Sedative and anaesthetic drug doses [During procedure]

    Doses of sedatives, analgesics and anaesthetics administered during the procedure

15. Acute Procedural Complications [Immediately after the procedure]

    Whether any complications occurred

16. Same-day discharge rates [24 hours]

    How many patients per arm went home on the same day as their procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liverpool Heart and Chest Hospital	Liverpool		United Kingdom

Sponsors and Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust

Investigators

• Study Chair: Dhiraj Gupta, MD, Liverpool Heart & Chest Hospital NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liverpool Heart and Chest Hospital NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT06014814
• Other Study ID Numbers: PFA-Sedation-Study; IRAS
• First Posted: Aug 28, 2023
• Last Update Posted: Sep 1, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Sep 1, 2023