Effect of Catheter Ablation on Clinical Course of Migraine in AF Patients With or Without Previous History of Migraine (CONFIRM)
Primary Purpose
Migraine, Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency catheter ablation
Radiofrequency catheter ablation
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
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
Sites / Locations
- St. David's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients without history of migraine
Patients with history of migraine
Arm Description
Incidence and prevalence of migraine episodes in the post-ablation period
Incidence and prevalence of migraine episodes in the post-ablation period
Outcomes
Primary Outcome Measures
Incidence of thrombo-embolic events and migraine
Secondary Outcome Measures
Impact of therapeutic Coumadin on the prevalence and clinical course of migraine in patients with a previous history
Full Information
NCT ID
NCT01391091
First Posted
May 26, 2011
Last Updated
October 17, 2016
Sponsor
Texas Cardiac Arrhythmia Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01391091
Brief Title
Effect of Catheter Ablation on Clinical Course of Migraine in AF Patients With or Without Previous History of Migraine
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients without history of migraine
Arm Type
Active Comparator
Arm Description
Incidence and prevalence of migraine episodes in the post-ablation period
Arm Title
Patients with history of migraine
Arm Type
Active Comparator
Arm Description
Incidence and prevalence of migraine episodes in the post-ablation period
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency catheter ablation
Other Intervention Name(s)
AF ablation, Pulmonary Vein Antral Ablation
Intervention Description
PVAI
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency catheter ablation
Other Intervention Name(s)
AF ablation, Pulmonary Vein Antral Ablation
Intervention Description
PVAI
Primary Outcome Measure Information:
Title
Incidence of thrombo-embolic events and migraine
Time Frame
6 and 12 months post-ablation
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luigi Di Biase, MD, Phd
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. David's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Catheter Ablation on Clinical Course of Migraine in AF Patients With or Without Previous History of Migraine
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