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

NCT ID: NCT01391091

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-04-30

Brief 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.

Conditions

Migraine; Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients without history of migraine

Incidence and prevalence of migraine episodes in the post-ablation period

Group Type: ACTIVE_COMPARATOR

Radiofrequency catheter ablation

Intervention Type: PROCEDURE

PVAI

Patients with history of migraine

Incidence and prevalence of migraine episodes in the post-ablation period

Group Type: ACTIVE_COMPARATOR

Radiofrequency catheter ablation

Intervention Type: PROCEDURE

PVAI

Interventions

Radiofrequency catheter ablation

PVAI

Intervention Type: PROCEDURE

Radiofrequency catheter ablation

PVAI

Intervention Type: PROCEDURE

Other Intervention Names

AF ablation; Pulmonary Vein Antral Ablation; AF ablation; Pulmonary Vein Antral Ablation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Cardiac Arrhythmia Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Andrea Natale

Medical director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Research Foundation

Luigi Di Biase, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Research Foundation

Locations

St. David's Medical Center

Austin, Texas, United States

Countries

United States

Other Identifiers

TCAI-CONFIRM

Identifier Type: -

Identifier Source: org_study_id