Anticoagulation in AF Ablation and Effects on Neurocognitive Function
Status: | Completed |
---|---|
Conditions: | Atrial Fibrillation, Cognitive Studies, Psychiatric |
Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2015 |
Start Date: | July 2014 |
End Date: | July 2015 |
Uninterrupted Versus Interrupted Anticoagulation in Atrial Fibrillation Ablation - Cerebral Thromboemboli and Neurocognitive Performance
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.
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.
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.
We found this trial at
1
site
533 Parnassus Ave
San Francisco, California 94122
San Francisco, California 94122
(415) 476-9000
University of California - San Francisco The leading university exclusively focused on health, UC San...
Click here to add this to my saved trials