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Anticoagulation in AF Ablation and Effects on Neurocognitive Function

NCT ID: NCT02120560

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation Cerebrothromboembolus Neurocognitive Function

Keywords

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Atrial Fibrillation Ablation Cerebrothromboemboli Neurocognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interrupted Anticoagulation

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).

Group Type ACTIVE_COMPARATOR

Atrial Fibrillation Ablation

Intervention Type PROCEDURE

Both treatment arms will undergo atrial fibrillation ablation.

Uninterrupted anticoagulation with warfarin

Patients randomized to undergo atrial fibrillation ablation with uninterrupted anticoagulation with warfarin (dosed case-by-case).

Group Type ACTIVE_COMPARATOR

Atrial Fibrillation Ablation

Intervention Type PROCEDURE

Both treatment arms will undergo atrial fibrillation ablation.

Interventions

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Atrial Fibrillation Ablation

Both treatment arms will undergo atrial fibrillation ablation.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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Deneke T, Shin DI, Balta O, Bunz K, Fassbender F, Mugge A, Anders H, Horlitz M, Pasler M, Karthikapallil S, Arentz T, Beyer D, Bansmann M. Postablation asymptomatic cerebral lesions: long-term follow-up using magnetic resonance imaging. Heart Rhythm. 2011 Nov;8(11):1705-11. doi: 10.1016/j.hrthm.2011.06.030. Epub 2011 Jul 2.

Reference Type BACKGROUND
PMID: 21726519 (View on PubMed)

Gaita F, Leclercq JF, Schumacher B, Scaglione M, Toso E, Halimi F, Schade A, Froehner S, Ziegler V, Sergi D, Cesarani F, Blandino A. Incidence of silent cerebral thromboembolic lesions after atrial fibrillation ablation may change according to technology used: comparison of irrigated radiofrequency, multipolar nonirrigated catheter and cryoballoon. J Cardiovasc Electrophysiol. 2011 Sep;22(9):961-8. doi: 10.1111/j.1540-8167.2011.02050.x. Epub 2011 Mar 31.

Reference Type BACKGROUND
PMID: 21453372 (View on PubMed)

Haeusler KG, Koch L, Herm J, Kopp UA, Heuschmann PU, Endres M, Schultheiss HP, Schirdewan A, Fiebach JB. 3 Tesla MRI-detected brain lesions after pulmonary vein isolation for atrial fibrillation: results of the MACPAF study. J Cardiovasc Electrophysiol. 2013 Jan;24(1):14-21. doi: 10.1111/j.1540-8167.2012.02420.x. Epub 2012 Aug 22.

Reference Type BACKGROUND
PMID: 22913568 (View on PubMed)

Herrera Siklody C, Deneke T, Hocini M, Lehrmann H, Shin DI, Miyazaki S, Henschke S, Fluegel P, Schiebeling-Romer J, Bansmann PM, Bourdias T, Dousset V, Haissaguerre M, Arentz T. Incidence of asymptomatic intracranial embolic events after pulmonary vein isolation: comparison of different atrial fibrillation ablation technologies in a multicenter study. J Am Coll Cardiol. 2011 Aug 9;58(7):681-8. doi: 10.1016/j.jacc.2011.04.010. Epub 2011 Jun 12.

Reference Type BACKGROUND
PMID: 21664090 (View on PubMed)

Ichiki H, Oketani N, Ishida S, Iriki Y, Okui H, Maenosono R, Ninomiya Y, Matsushita T, Miyata M, Hamasaki S, Tei C. Incidence of asymptomatic cerebral microthromboembolism after atrial fibrillation ablation guided by complex fractionated atrial electrogram. J Cardiovasc Electrophysiol. 2012 Jun;23(6):567-73. doi: 10.1111/j.1540-8167.2011.02259.x. Epub 2012 Feb 7.

Reference Type BACKGROUND
PMID: 22313240 (View on PubMed)

Other Identifiers

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14-13595

Identifier Type: -

Identifier Source: org_study_id