STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?

June 27, 2023 updated by: Abbott Medical Devices
The primary objective of this Study is to compare the effect of transcatheter device closure of atrial shunting to a non-closure control group over a period from cessation of procedure related medication at 3 months until 9 months post randomization by determining the proportion of patients that experience a 50% or more reduction in the baseline monthly migraine attack frequency in each group.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

656

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60389
        • CardioVascular Center Frankfurt, Sankt Katharinen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Migraine history of at least 1 year.
  • Migraine patients experiencing at least 2 migraine attacks per month.
  • Migraine patients experiencing at least 1 migraine attack with aura per month.
  • Failure of or intolerance to at least 2 classes of prophylactic migraine medication evaluated in adequate, approved medication trials. At least one of the classes shall come from beta-blockers, anticonvulsants, calcium channel blockers and tricyclic antidepressants.
  • Aged 18 - 50 years and of legal age in the host country.
  • The patient or legal guardian has signed a study specific informed consent form agreeing to data collection and follow-up requirements.
  • The patient agrees to abstain from starting prophylactic migraine medication or agrees to maintain existing prophylactic migraine medication without changing dose or drug from entering the baseline period throughout the duration of the study until final assessments.
  • Documented right to left shunt that is suitable for device closure.

Exclusion Criteria:

  • Taking migraine preventative medication for conditions other than migraine.
  • History of 15 or more headache days per month.
  • 8 or more non-migraine headache days per month.
  • Overuse of acute headache medication (use on 10 or more days per month).
  • Patient has severe central nervous system disease such as seizure disorder, inflammatory disease of the central nervous system, or a previous stroke.
  • Previous surgical or device closure of a PFO or ASD.
  • Artificial heart valve.
  • Pacemaker or ICD implanted within past 3 months.
  • Anatomic variant that could affect successful deployment such as coronary sinus, pulmonary veins, Chiari network.
  • Uncontrolled bacteremias or dental or surgical procedure within past 30 days or planned within study period.
  • Allergy to contrast media, and/or to any component of the device to be used.
  • Contraindicated for any medication used during or after the procedure.
  • History of atrial fibrillation or atrial flutter (chronic or paroxysmal).
  • Patient is enrolled or intends to participate in another clinical study (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrollment in the study.
  • Patient is undergoing dialysis for renal failure.
  • Patient has NYHA class 3 or 4 cardiac failure.
  • Patient is pregnant, or intends to become pregnant during the trial period.
  • Patient requires anticoagulation therapy for a concomitant condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean values of the number of monthly migraine periods, with or without aura.

Secondary Outcome Measures

Outcome Measure
Mean values of monthly migraine frequency with or without aura.
Quality of life using a Headache Impact Test Questionnaire.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Michel Ferrari, Prof., Leiden University Medical Centre
  • Principal Investigator: Horst Sievert, Prof., CardioVascular Center Frankfurt, Sankt Katharinen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 28, 2006

First Submitted That Met QC Criteria

August 28, 2006

First Posted (Estimated)

August 29, 2006

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV05003PC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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