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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01391091
First received: May 26, 2011
Last updated: April 8, 2014
Last verified: August 2013

May 26, 2011
April 8, 2014
December 2010
December 2013   (final data collection date for primary outcome measure)
Incidence of thrombo-embolic events and migraine [ Time Frame: 6 and 12 months post-ablation ] [ Designated as safety issue: Yes ]
Incidence of thrombo-embolic events and migraine [ Time Frame: 3 months post-ablation ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01391091 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Impact of therapeutic Coumadin on the prevalence and clinical course of migraine in patients with a previous history [ Time Frame: 3-months post-ablation ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effect of Catheter Ablation on Clinical Course of Migraine in AF Patients With or Without Previous History of Migraine
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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Migraine
  • Atrial Fibrillation
Procedure: Radiofrequency catheter ablation
PVAI
Other Names:
  • AF ablation
  • Pulmonary Vein Antral Ablation
  • Active Comparator: Patients without history of migraine
    Incidence and prevalence of migraine episodes in the post-ablation period
    Intervention: Procedure: Radiofrequency catheter ablation
  • Active Comparator: Patients with history of migraine
    Incidence and prevalence of migraine episodes in the post-ablation period
    Intervention: Procedure: Radiofrequency catheter ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
December 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01391091
TCAI-CONFIRM
No
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
Texas Cardiac Arrhythmia Research Foundation
Not Provided
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Luigi Di Biase, MD, Phd Texas Cardiac Arrhythmia Research Foundation
Texas Cardiac Arrhythmia Research Foundation
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP