Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014814
Status:
RECRUITING
Last Update Posted:
2023-09-01
First Post:
2023-07-17
Brief Title:
Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation
Sponsor:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Organization:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Study Overview
Official Title:
Pulsed Field Ablation Under Mild Conscious Sedation - A Feasibility Study
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective case-control study comparing pulsed field ablation for atrial fibrillation under mild conscious sedation vs standard of care general anaesthesia
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRAS | OTHER | 320883 | None |