Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation

NCT ID: NCT06014814

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-21

Study Completion Date

2024-06-11

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulsed Field Ablation - General Anaesthesia

Patients undergoing pulsed field ablation for atrial fibrillation under general anaesthetic.

Catheter ablation

Intervention Type PROCEDURE

Catheter ablation of atrial fibrillation

Pulsed Field Ablation - Mild Conscious Sedation

Patients undergoing pulsed field ablation for atrial fibrillation under mild conscious sedation.

Catheter ablation

Intervention Type PROCEDURE

Catheter ablation of atrial fibrillation

Interventions

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Catheter ablation

Catheter ablation of atrial fibrillation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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IRAS

Identifier Type: OTHER

Identifier Source: secondary_id

PFA-Sedation-Study

Identifier Type: -

Identifier Source: org_study_id

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