Ignite Creation Date:
2024-05-06 @ 2:01 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01959425
Status:
TERMINATED
Last Update Posted:
2020-12-17
First Post:
2013-10-08
Brief Title:
Oral Anticoagulation Therapy Pilot Study
Sponsor:
Biosense Webster Inc
Organization:
Biosense Webster Inc
Study Overview
Official Title:
Safety of Oral Anticoagulation Therapy Withdrawal After Successful Cardiac Ablation in Patients With Atrial Fibrillation and Associated High Risk Factors for Embolic Events OAT Pilot Study
Status:
TERMINATED
Status Verified Date:
2020-11
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:
OAT
Brief Summary:
The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation
Detailed Description:
Patients undergoing successful cardiac ablation for atrial fibrillation who remain AF recurrence-free 3 months after successful ablation and continue to meet the inclusionexclusion criteria will be screened for enrollment in the trial After fulfilling all of the inclusionexclusion criteria patients who consent to participate in the study and remain AF recurrence-free will be randomized to one of two study arms 1 OAT Withdrawal Test Group or 2 OAT Control Group and participate in the Evaluation Period 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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