Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04575662
Status:
UNKNOWN
Last Update Posted:
2022-08-09
First Post:
2020-09-29
Brief Title:
Radiotherapy and Atrial Fibrillation
Sponsor:
Miulli General Hospital
Organization:
Miulli General Hospital
Study Overview
Official Title:
Linac Based STereotactic Arrhythmia Radioablation STAR of Atrial Fibrillation
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
STAR
Brief Summary:
Atrial fibrillation AF is the most common sustained cardiac arrhythmia Current European guidelines recommend catheter ablation of AF in symptomatic patients refractory to antiarrhythmic therapy Pulmonary vein isolation PVI remains the cornerstone of any ablation procedure irrespective of patient characteristics Recently stereotactic arrhythmia radioablation STAR with precise high-dose of radiation was used to treat ventricular arrhythmias in patients with a high risk of complications during transcatheter ablation
Detailed Description:
Exploratory study to investigate the feasibility of STAR for the treatment of paroxysmal AF in elderly patients in which a rhythm control strategy is indicated Patients will be followed-up for 12 months after STAR treatment for a safety assessment and AF recurrence
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