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Anticoagulation in AF Ablation and Effects on Neurocognitive Function

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ClinicalTrials.gov Identifier: NCT02120560
Recruitment Status : Withdrawn
First Posted : April 22, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE April 18, 2014
First Posted Date  ICMJE April 22, 2014
Last Update Posted Date December 12, 2014
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2014)
  • Incidence of stroke [ Time Frame: 4 weeks ]
    The incidence of peri-procedural stroke will be measured.
  • Incidence of Cerebrothromboemboli [ Time Frame: 1 day ]
    The incidence of cerebrothromboemboli post-ablation will be measured by comparing post-procedural brain MRI to pre-procedural brain MRI.
  • Change in Neurocognitive Performance [ Time Frame: approximately 4 weeks ]
    Change in neurocognitive function will be measured by comparing performance on a battery of validated neurocognitive tests to pre-procedural performance.
  • Bleeding Complications [ Time Frame: approximately 1 week ]
    The incidence of intra- and post-procedural bleeding complications, specifically hemopericardium and groin access complications, will be measured.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02120560 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticoagulation in AF Ablation and Effects on Neurocognitive Function
Official Title  ICMJE Uninterrupted Versus Interrupted Anticoagulation in Atrial Fibrillation Ablation - Cerebral Thromboemboli and Neurocognitive Performance
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Cerebrothromboembolus
  • Neurocognitive Function
Intervention  ICMJE Procedure: Atrial Fibrillation Ablation
Both treatment arms will undergo atrial fibrillation ablation.
Study Arms  ICMJE
  • Active Comparator: 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).
    Intervention: Procedure: Atrial Fibrillation Ablation
  • Active Comparator: Uninterrupted anticoagulation with warfarin
    Patients randomized to undergo atrial fibrillation ablation with uninterrupted anticoagulation with warfarin (dosed case-by-case).
    Intervention: Procedure: Atrial Fibrillation Ablation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 10, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2014)
88
Estimated Study Completion Date  ICMJE July 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02120560
Other Study ID Numbers  ICMJE 14-13595
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Francisco
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP