Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation
Pulsed Field Ablation Under Mild Conscious Sedation - A Feasibility Study
2 other identifiers
observational
40
1 country
1
Brief Summary
Prospective case-control study comparing pulsed field ablation for atrial fibrillation under mild conscious sedation vs standard of care (general anaesthesia).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2023
CompletedStudy Start
First participant enrolled
August 21, 2023
CompletedFirst Posted
Study publicly available on registry
August 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2024
CompletedNovember 4, 2024
October 1, 2024
10 months
July 17, 2023
October 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
Patient experience (Pain; Relative)
Intraprocedural
Patient experience (Discomfort; Relative)
Intraprocedural
Patient experience (Anxiety; Relative)
Intraprocedural
Patient experience (Pain; Absolute)
Intraprocedural
Patient experience (Discomfort; Absolute)
Intraprocedural
- +11 more secondary outcomes
Study Arms (2)
Pulsed Field Ablation - General Anaesthesia
Patients undergoing pulsed field ablation for atrial fibrillation under general anaesthetic.
Pulsed Field Ablation - Mild Conscious Sedation
Patients undergoing pulsed field ablation for atrial fibrillation under mild conscious sedation.
Interventions
Catheter ablation of atrial fibrillation
Eligibility Criteria
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.
You may qualify if:
- Patients clinically referred for and undergoing catheter ablation of atrial fibrillation using pulsed field ablation
You may not qualify if:
- Inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2023
First Posted
August 28, 2023
Study Start
August 21, 2023
Primary Completion
June 11, 2024
Study Completion
June 11, 2024
Last Updated
November 4, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Anonymised dataset can be made available upon reasonable request. Identifiable data will not be made available for confidentiality reasons.