Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656884
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
FARAPULSE Workflow Assessment Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
FARAPULSE Workflow Assessment Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FARAWAY
Brief Summary:
The study is designed to determine the best practices in the patient pathway and to analyze pre-procedural procedural and follow-up workflow data related with ablation of atrial fibrillation where the FARAPULSE Pulsed Field Ablation System is used in a commercial and standard of care setting Workflow-related variables inclusive of pre-procedural imaging methods of transseptal access anesthesiasedation technique intracardiac mapping ablation settings dosing strategy lesion sets and general procedure management will be used to identify predominant workflow schemes that will be associated with patient demographics procedure-related complications safety parameters and one-year effectiveness parameters
The study data can be used for procedural workflow optimization when using Pulsed Field Ablation for the ablation treatment of Atrial Fibrillation based on patient demographics cardiac anatomy and arrhythmia characteristics
The study data can be used for procedural workflow optimization when using Pulsed Field Ablation for the ablation treatment of Atrial Fibrillation based on patient demographics cardiac anatomy and arrhythmia characteristics
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None