Skip to main content
OpenTrials
Completed

NCT Number: NCT01391091

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. David's Medical Center

Austin, Texas, 78705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiofrequency catheter ablation

Procedure

PVAI

Other names: AF ablation, Pulmonary Vein Antral Ablation

Primary outcomes

  1. Incidence of thrombo-embolic events and migraine

    Time frame: 6 and 12 months post-ablation

Secondary outcomes

  1. Impact of therapeutic Coumadin on the prevalence and clinical course of migraine in patients with a previous history

    Time frame: 6 and 12 months post-ablation

Sponsors and collaborators

Lead sponsor

Texas Cardiac Arrhythmia Research Foundation

Other

Registry information

Official study 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

Acronym: CONFIRM

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jul 11, 2011
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.