Effect of Catheter Ablation on Clinical Course of Migraine in AF Patients With or Without Previous History of Migraine
Condition: Migraine; Atrial Fibrillation
MeSH terms: Migraine Disorders; Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this prospective study is to evaluate the effect of catheter ablation on
      incidence, prevalence and disease-severity of migraine in AF patients undergoing ablation,
      with or without a history of migraine.
    

Detailed description: 
      Migraine, a neurovascular disorder affecting approximately 12% of world population, is
      characterized by recurrent attacks of incapacitating headache associated with photophobia,
      phonophobia, nausea and vomiting (1). Although the pathogenesis of migraine is not clearly
      understood yet, it has been widely accepted as being caused by cerebral vasodilatation,
      abnormal neurological firings and/or neurogenic dural inflammation (1). Additionally, recent
      studies have demonstrated an association between migraine with aura and intracardiac shunting
      by a patent foramen ovale (PFO) leading to a hypothesis that paradoxical brain embolism of
      platelets and other undefined chemical substances can play a causal role in migraine with
      aura (2).

      Radiofrequency catheter ablation (RFCA) has been shown to be a promising treatment for
      cardiac arrhythmias. During catheter ablation, trans-septal puncture (TSP) is routinely
      performed to gain access to the left heart. TSP causes an iatrogenic atrial septal defect
      (ASD) with a transient right-to-left shunt which can predispose patients to stroke and
      migraine (3). In two different studies, with 571 and 183 patients in whom TSP was performed,
      the incidence of migraine was 0.5% and 2.2% respectively and the migraine was transient and
      resolved without any sequelae (2, 3). In separate studies, complete resolution or improvement
      of migraine was noticed with the ASD/PFO closure (4). Additional case-studies have also
      reported AF occurring during episodes of migraine with aura where the cardiac rhythm was
      normal between the episodes (5). All these reports evidently demonstrate an association
      between AF, TSP during RFCA and migraine, but fail to clearly define the nature of it. It is
      not yet understood whether a successful catheter ablation of AF has any impact on the natural
      course of pre-existing or newly-occurring migraine. This study aims at exploring the
      relationship between AF and migraine and to evaluate if an effective ablation therapy for AF
      influences the incidence and clinical presentation of migraine in patients with or without a
      previous history.

      Several isolated case-studies have reported improvement in the frequency and severity of
      migraine during treatment with Coumadin (6, 7). Coumadin is routinely prescribed to patients
      undergoing RFCA to prevent thrombo-embolic events. Our study would further explore the impact
      of therapeutic Coumadin on the prevalence and clinical course of migraine in patients with a
      previous history.

      Hypothesis: Catheter ablation affects the disease course of migraine in AF patients with or
      without a previous history of migraine.
    

Intervention name(s): Radiofrequency catheter ablation; Radiofrequency catheter ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): PVAI; PVAI
Other intervention name(s): AF ablation; Pulmonary Vein Antral Ablation; AF ablation; Pulmonary Vein Antral Ablation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment