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Completed

NCT Number: NCT06014814

Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inability to provide informed consent

Treatment and study plan

Catheter ablation

Procedure

Catheter ablation of atrial fibrillation

Primary outcomes

  1. Number and Percentage of Patients Converting to General Anaesthesia in the Conscious Sedation Arm

    Time frame: Intraprocedural

    Requirement for conversion to general anaesthesia from mild conscious sedation

Secondary outcomes

  1. Patient experience (Pain; Relative)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Intraprocedural

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

  5. Patient experience (Discomfort; Absolute)

    Time frame: 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)

    Time frame: Intraprocedural

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

  7. Post-operative discomfort (Visual analogue score)

    Time frame: 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

    Time frame: 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

    Time frame: Immediately after the procedure

    Were all pulmonary veins isolated at procedure end?

  10. Procedure Duration

    Time frame: During procedure

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

  11. Fluoroscopy Duration

    Time frame: During procedure

    Time spent with x-ray active

  12. Left atrial dwell time

    Time frame: During procedure

    Time spent with catheters inside the left atrium

  13. Ablation Duration

    Time frame: During procedure

    Time from first ablation application to end of final ablation application

  14. Sedative and anaesthetic drug doses

    Time frame: During procedure

    Doses of sedatives, analgesics and anaesthetics administered during the procedure

  15. Acute Procedural Complications

    Time frame: Immediately after the procedure

    Whether any complications occurred

  16. Same-day discharge rates

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Other

Registry information

Official study title

Pulsed Field Ablation Under Mild Conscious Sedation - A Feasibility Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2023
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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