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

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Atrial Fibrillation
• Intervention / Treatment: Procedure: Radiofrequency catheter ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • St. David's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients without history of migraine; Incidence and prevalence of migraine episodes in the post-ablation period	Procedure: Radiofrequency catheter ablation; PVAI; Other Names: AF ablation; Pulmonary Vein Antral Ablation
Active Comparator: Patients with history of migraine; Incidence and prevalence of migraine episodes in the post-ablation period	Procedure: Radiofrequency catheter ablation; PVAI; Other Names: AF ablation; Pulmonary Vein Antral Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of thrombo-embolic events and migraine	6 and 12 months post-ablation

Secondary Outcome Measures

Outcome Measure	Time Frame
Impact of therapeutic Coumadin on the prevalence and clinical course of migraine in patients with a previous history	6 and 12 months post-ablation

Collaborators and Investigators

• Sponsor: Texas Cardiac Arrhythmia Research Foundation

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Headache Disorders, Primary; Headache Disorders; Atrial Fibrillation; Migraine Disorders
• Other Study ID Numbers: TCAI-CONFIRM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No