Effect of Catheter Ablation on Clinical Course of Migraine in AF Patients With or Without Previous History of Migraine

Atrial Fibrillation Clinical Trial

— CONFIRM  

Official title:

Effect of Catheter Ablation on the Prevalence, Clinical Manifestation and MRI Findings of Migraine in AF Patients With or Without a Previous History of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391091
• Other study ID #: TCAI-CONFIRM
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2011
• Last updated: October 17, 2016
• Start date: December 2010
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: April 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age: 18-75 years

• AF patients undergoing RFCA

• Ability to distinguish migraine attacks as discrete from other headaches (i.e., tension-headache)

• Ability to read, comprehend, and legibly and reliably record information

• Ability to provide written, informed consent

Exclusion Criteria:

• Uncontrollable hypertension

• History of stroke, TIA or epilepsy

• Bleeding disorder

• Hypersensitivity, allergy or contraindications to the use of NSAIDs, Triptans, Aspirin or Warfarin

• Contraindication to undergoing an MRI

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Migraine
• Migraine Disorders

Intervention

Procedure:
• Radiofrequency catheter ablation
PVAI
• Radiofrequency catheter ablation
PVAI

Locations

Country	Name	City	State
United States	St. David's Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of thrombo-embolic events and migraine		6 and 12 months post-ablation	Yes
Secondary	Impact of therapeutic Coumadin on the prevalence and clinical course of migraine in patients with a previous history		6 and 12 months post-ablation	Yes