MigrainePhase 3CONFIRMNCT01391091
Effect of Catheter Ablation on Clinical Course of Migraine in AF Patients With or Without Previous History of Migraine
A Phase 3 study testing Radiofrequency catheter ablation in people with Migraine and Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine, Atrial Fibrillation
- What is being tested?
- Radiofrequency catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Radiofrequency catheter ablation
- Medical subject headings
- Migraine Disorders, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency catheter ablationProcedure or surgery
Also called AF ablation, Pulmonary Vein Antral Ablation
PVAI
Radiofrequency catheter ablationProcedure or surgery
Also called AF ablation, Pulmonary Vein Antral Ablation
PVAI
| Study group | Role | What they receive |
|---|---|---|
| Patients without history of migraine | Active comparator | Incidence and prevalence of migraine episodes in the post-ablation period Receives: Procedure: Radiofrequency catheter ablation |
| Patients with history of migraine | Active comparator | Incidence and prevalence of migraine episodes in the post-ablation period Receives: Procedure: Radiofrequency catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of thrombo-embolic events and migraine
Measured: 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
Measured: 6 and 12 months post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionApr 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
- Investigators
- Andrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Research FoundationLuigi Di Biase, MD, Phd, Principal investigator, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391091
- Sponsor's protocol ID
- TCAI-CONFIRM
- Acronym
- CONFIRM
- Status last verified
- May 2015
- First submitted
- 26 May 2011
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01391091
- Acronym / sponsor ID
- CONFIRM / TCAI-CONFIRM
- Conditions
- Migraine, Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without history of migraine | Active comparator | Procedure: Radiofrequency catheter ablationIncidence and prevalence of migraine episodes in the post-ablation period |
| Patients with history of migraine | Active comparator | Procedure: Radiofrequency catheter ablationIncidence and prevalence of migraine episodes in the post-ablation period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency catheter ablationAlso: AF ablation, Pulmonary Vein Antral AblationPVAI | Procedure or surgery | Patients without history of migraine |
| Radiofrequency catheter ablationAlso: AF ablation, Pulmonary Vein Antral AblationPVAI | Procedure or surgery | Patients with history of migraine |
Primary outcome
Incidence of thrombo-embolic events and migraine
Time frame: 6 and 12 months post-ablation
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natale, MD principal investigator
Texas Cardiac Arrhythmia Research Foundation
Luigi Di Biase, MD, Phd principal investigator
Texas Cardiac Arrhythmia Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiofrequency catheter ablation in people with Migraine and Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of thrombo-embolic events and migraine (time frame: 6 and 12 months post-ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.