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Trial record 28 of 221 for:    heart disease AND stroke AND California

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Recruitment Status : Withdrawn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

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Cerebrothromboembolus Neurocognitive Function Procedure: Atrial Fibrillation Ablation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uninterrupted Versus Interrupted Anticoagulation in Atrial Fibrillation Ablation - Cerebral Thromboemboli and Neurocognitive Performance
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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).
Procedure: Atrial Fibrillation Ablation
Both treatment arms will undergo 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).
Procedure: Atrial Fibrillation Ablation
Both treatment arms will undergo atrial fibrillation ablation.



Primary Outcome Measures :
  1. Incidence of stroke [ Time Frame: 4 weeks ]
    The incidence of peri-procedural stroke will be measured.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120560


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02120560     History of Changes
Other Study ID Numbers: 14-13595
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by University of California, San Francisco:
Atrial Fibrillation Ablation
Cerebrothromboemboli
Neurocognitive Function

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants