Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216769
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-01-11
Brief Title:
Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Comparison Between Continuous Oral Anticoagulation Versus Pill-in-the-POCKET Oral AntiCoagulation Strategy Guided by Continuous Rhythm Monitoring Using Implantable Loop Recorder After Atrial Fibrillation Catheter Ablation
Status:
RECRUITING
Status Verified Date:
2024-05
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:
POCKET-OAC
Brief Summary:
The clinical benefit of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation remains uncertain We aimed to evaluate the clinical benefit and safety of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation by randomizing into two groups non-interrupted anticoagulation after the procedure and anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders
Detailed Description:
Atrial fibrillation significantly increases the risk of thromboembolic complications including stroke Accordingly current atrial fibrillation treatment guidelines recommend lifelong prescription of anticoagulants if the CHA2DS2-VASc score is 2 for males or 3 for females or higher Class IA With the recent advances in rhythm control treatment through catheter ablation in atrial fibrillation patients increasing concerns are being raised about the need to continue anticoagulation after successful catheter ablation However current guidelines still require continued anticoagulation based on the baseline CHA2DS2-VASc score regardless of sinus conversion after atrial fibrillation catheter ablation
A recently published observational study demonstrated that the risk of stroke was reduced by less than 07 per year in patients who discontinued anticoagulants after successful catheter ablation Subsequent meta-analysis studies similarly suggested that anticoagulant discontinuation could be safe in patients whose rhythm was restored to sinus rhythm through catheter ablation In addition it was confirmed that anticoagulant discontinuation after catheter ablation was associated with only a 06 increase in the risk of thromboembolism as opposed to a 18 decrease in the risk of severe bleeding such as intracranial hemorrhage and respiratory bleeding Similar findings were also confirmed from large-scale non-randomized studies However there is still a lack of large-scale randomized study findings to support that anticoagulant discontinuation is appropriate in atrial fibrillation who are successful converted to sinus rhythm after catheter ablation
Two single-arm pilot studies have been published about pill-in-the-pocket PIP anticoagulation One is the REACTCOM Rhythm Evaluation for Anticoagulation With Continuous Monitoring and the other is the TACTIC-AF Tailored Anticoagulation for Non-Continuous Atrial Fibrillation In the above studies continuous remote monitoring was performed using insertable cardiac monitors dual-chamber pacemakers or defibrillators If atrial fibrillation persisted over a certain period during monitoring anticoagulation was resumed for 30 days This approach reduced the use of anticoagulants by 94 in the REACTCOM by resuming anticoagulation when atrial fibrillation recurrence persisted longer than 1 hour TACTIC-AF observed a 75 reduction in time on anticoagulation using a threshold of 6 minutes or total burden 6 hd
Conventionally recurrence of atrial fibrillation has been confirmed through 12-lead electrocardiogram ECG or adhesive 24-hour or 3-day 7-day 2-week ECG monitoring However these methods are limited by the inability to continuously assess the exact atrial fibrillation burden during the follow-up period As an alternative to this implantable loop recorders ILR enabled with continuous heart rhythm monitoring have recently been widely used in clinical practice These implantable loop recorders have shown desirable performance in measuring atrial fibrillation recurrence and burden However few studies have evaluated the role of continuous rhythm monitoring in guiding OAC in patients with AF
This study is aimed to evaluate clinical benefits including the appropriateness efficacy and safety of pill-in-the-POCKET anticoagulation and establish its cost-effectiveness by comparing the incidence of major clinical events after randomization of atrial fibrillation patients scheduled to undergo catheter ablation into two groups non-interrupted anticoagulation after the procedure and resumed anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders
A recently published observational study demonstrated that the risk of stroke was reduced by less than 07 per year in patients who discontinued anticoagulants after successful catheter ablation Subsequent meta-analysis studies similarly suggested that anticoagulant discontinuation could be safe in patients whose rhythm was restored to sinus rhythm through catheter ablation In addition it was confirmed that anticoagulant discontinuation after catheter ablation was associated with only a 06 increase in the risk of thromboembolism as opposed to a 18 decrease in the risk of severe bleeding such as intracranial hemorrhage and respiratory bleeding Similar findings were also confirmed from large-scale non-randomized studies However there is still a lack of large-scale randomized study findings to support that anticoagulant discontinuation is appropriate in atrial fibrillation who are successful converted to sinus rhythm after catheter ablation
Two single-arm pilot studies have been published about pill-in-the-pocket PIP anticoagulation One is the REACTCOM Rhythm Evaluation for Anticoagulation With Continuous Monitoring and the other is the TACTIC-AF Tailored Anticoagulation for Non-Continuous Atrial Fibrillation In the above studies continuous remote monitoring was performed using insertable cardiac monitors dual-chamber pacemakers or defibrillators If atrial fibrillation persisted over a certain period during monitoring anticoagulation was resumed for 30 days This approach reduced the use of anticoagulants by 94 in the REACTCOM by resuming anticoagulation when atrial fibrillation recurrence persisted longer than 1 hour TACTIC-AF observed a 75 reduction in time on anticoagulation using a threshold of 6 minutes or total burden 6 hd
Conventionally recurrence of atrial fibrillation has been confirmed through 12-lead electrocardiogram ECG or adhesive 24-hour or 3-day 7-day 2-week ECG monitoring However these methods are limited by the inability to continuously assess the exact atrial fibrillation burden during the follow-up period As an alternative to this implantable loop recorders ILR enabled with continuous heart rhythm monitoring have recently been widely used in clinical practice These implantable loop recorders have shown desirable performance in measuring atrial fibrillation recurrence and burden However few studies have evaluated the role of continuous rhythm monitoring in guiding OAC in patients with AF
This study is aimed to evaluate clinical benefits including the appropriateness efficacy and safety of pill-in-the-POCKET anticoagulation and establish its cost-effectiveness by comparing the incidence of major clinical events after randomization of atrial fibrillation patients scheduled to undergo catheter ablation into two groups non-interrupted anticoagulation after the procedure and resumed anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders
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