Anticoagulation in AF Ablation & Effects on Neurocognitive Function

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02120560
Study type	Interventional
Source	University of California, San Francisco
Contact
Status	Withdrawn
Phase	Phase 4
Start date	July 2014
Completion date	July 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Anticoagulation in AF Ablation and Effects on Neurocognitive Function

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms