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

NCT01391091 | Completed Phase 3

• 1 other identifier: TCAI-CONFIRM
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Incidence of thrombo-embolic events and migraine

  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

  6 and 12 months post-ablation

Study Arms (2)

Patients without history of migraine

ACTIVE COMPARATOR

Incidence and prevalence of migraine episodes in the post-ablation period

Procedure: Radiofrequency catheter ablation

Patients with history of migraine

ACTIVE COMPARATOR

Incidence and prevalence of migraine episodes in the post-ablation period

Procedure: Radiofrequency catheter ablation

Interventions

Radiofrequency catheter ablation PROCEDURE

PVAI

Also known as: AF ablation, Pulmonary Vein Antral Ablation

Patients without history of migraine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

Study Sites (1)

St. David's Medical Center

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

• Luigi Di Biase, MD, Phd

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: July 11, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2014
• Last Updated: October 18, 2016

Record last verified: 2015-05

Locations

US (1)