Anticoagulation in AF Ablation and Effects on Neurocognitive Function

Phase 4

Withdrawn

• Conditions: Cerebrothromboembolus; Atrial Fibrillation; Neurocognitive Function
• Interventions: Procedure: Atrial Fibrillation Ablation

• Registration Number: NCT02120560
• Lead Sponsor: University of California, San Francisco

Brief Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the United States, and treatment by AF ablation is quickly becoming the favored definitive therapy. Nonetheless, AF ablation comes with some risk, including bleeds related to vascular access and myocardial damage, as well as the rare incidence of clinical stroke from blood clots that travel from the heart to the brain, termed "cerebrothromboemboli." In fact, cerebrothromboemboli without any symptoms have been detected by special imaging procedures called brain magnetic resonance imaging (MRI) in as many as 22% of cases.(1-6) There remains clinical equipoise amongst experts regarding balancing the risks and benefits of continued versus interrupted blood thinning, or "anticoagulation" during AF ablation as they pertain to risk of bleed and cerebrothromboemboli prevention, respectively, and the potentially more subtle sequelae of these apparently silent cerebrothromboemboli remain unknown. In fact, both interruption and continuation of anticoagulation during AF ablation are the standard of care. The investigators will perform the first randomized trial of uninterrupted versus interrupted anticoagulation in patients undergoing AF ablation to determine if it mitigates neurologic injury. The objective of this research is to investigate the effect of continued anticoagulation for AF ablation on cerebrothromboemboli, and the neurocognitive sequelae of embolic lesions, which to this point are considered subclinical. The investigators hypothesize that continued anticoagulation will both reduce cerebrothromboemboli and mitigate any potential decline in neurocognitive function post-procedurally. The investigators also hypothesize that the incidence of cerebrothromboemboli (CTE) by MRI will mediate that difference.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-21
• Study First Posted: 2014-04-22
• Study Start: 2014-07
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-12
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients 18 years old and older with AF (paroxysmal or persistent) who are to undergo an elective AF ablation procedure at UCSF will be eligible for enrollment.

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Exclusion Criteria

• Patients will be excluded if they have:
• A contraindication of warfarin therapy (pregnancy, recent bleed, inability of have serial INR checks)
• A contraindication or relative contraindication to interruption of anticoagulation (e.g. mechanical valve, clotting disorder such as antiphospholipid syndrome, recent history of pulmonary embolism or history of recurrent pulmonary embolism)
• A contraindication to transesophageal echocardiogram; any contraindication to MRI
• Have a diagnosed condition of dementia or a diagnosis that precludes accurate assessment of neurocognitive function
• Non-English speakers
• Inability to give informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uninterrupted anticoagulation with warfarin	Atrial Fibrillation Ablation	Patients randomized to undergo atrial fibrillation ablation with uninterrupted anticoagulation with warfarin (dosed case-by-case).
Interrupted Anticoagulation	Atrial Fibrillation Ablation	Patients randomized to undergo atrial fibrillation ablation with interrupted anticoagulation with apixaban (5mg twice daily; 2.5mg twice daily \>80 years old, Cr \> 1.5, wt \< 60kg), rivaroxaban (20mg daily; 15mg daily CrCl \< 50 mL/minute), dabigatran (150mg twice daily; 75mg twice daily CrCl \< 30mL/minute), or warfarin (dosed case-by-case).

Primary Outcome Measures

Name	Time	Method
Incidence of stroke	4 weeks	The incidence of peri-procedural stroke will be measured.
Incidence of Cerebrothromboemboli	1 day	The incidence of cerebrothromboemboli post-ablation will be measured by comparing post-procedural brain MRI to pre-procedural brain MRI.
Bleeding Complications	approximately 1 week	The incidence of intra- and post-procedural bleeding complications, specifically hemopericardium and groin access complications, will be measured.
Change in Neurocognitive Performance	approximately 4 weeks	Change in neurocognitive function will be measured by comparing performance on a battery of validated neurocognitive tests to pre-procedural performance.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States