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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
  Purpose

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.


Condition Intervention Phase
Migraine
Atrial Fibrillation
Procedure: Radiofrequency catheter ablation
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • Incidence of thrombo-embolic events and migraine [ Time Frame: 6 and 12 months post-ablation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391091

Locations
United States, Texas
St. David's Medical Center
Austin, Texas, United States, 78705
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Luigi Di Biase, MD, Phd Texas Cardiac Arrhythmia Research Foundation
  More Information

No publications provided

Responsible Party: Andrea Natale, Medical director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01391091     History of Changes
Other Study ID Numbers: TCAI-CONFIRM
Study First Received: May 26, 2011
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Migraine Disorders
Arrhythmias, Cardiac
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Heart Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 19, 2014