Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615596
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation DESTINATION Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
DESTINATION
Brief Summary:
The DESTINATION Study investigates whether anticoagulation therapy is necessary after successful catheter ablation CA for atrial fibrillation AF Current guidelines recommend continued anticoagulation based on stroke risk scores even post-ablation potentially exposing patients to unnecessary bleeding risks This international multicenter randomized controlled trial aims to compare thromboembolic and bleeding event risks between patients who continue and discontinue anticoagulation after ablation The study involves 3160 AF patients all free of AF recurrence within 6 months to 1 year after ablation Smart wearable monitors will track recurrence and patients are followed for 24 months to assess event rates Findings may reshape anticoagulation guidelines improving clinical practice for AF patients worldwide
Detailed Description:
This prospective international multicenter randomized controlled trial RCT investigates the safety and necessity of continuing anticoagulation therapy after successful catheter ablation of atrial fibrillation The study will enroll 3160 patients who underwent catheter ablation for AF and achieved no recurrence within 6 months to 1 year post-procedure Participants will be randomly assigned to either continue or discontinue anticoagulation therapy Smart wearable devices will monitor AF recurrence every 3 months detecting both symptomatic and asymptomatic events The study39s primary endpoint is a composite of ischemic stroke systemic embolism and major bleeding at a 24-month follow-up Secondary outcomes include AF recurrence rates re-ablation needs and quality of life measures Participants are monitored through follow-up visits at 3 6 12 18 and 24 months and data from wearable devices will be transmitted to the research team This study is significant due to the diversity of the population with sites in China and the US allowing for results that are generalizable across ethnic and geographic lines The trial39s findings aim to provide high-quality evidence to inform future guideline recommendations regarding post-ablation anticoagulation therapy potentially reducing unnecessary bleeding risks and optimizing treatment outcomes The inclusion of smart wearable monitors enhances the detection of asymptomatic recurrences and provides continuous reliable data on patient health during the follow-up period
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