PRIMA PFO Migraine Trial

NCT ID: NCT00505570

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

Detailed Description

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The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.

Conditions

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Migraine Migraine With Aura Patent Foramen Ovale PFO

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Medical Management

Group Type NO_INTERVENTION

No interventions assigned to this group

PFO Closure

Group Type EXPERIMENTAL

AMPLATZER® PFO Occluder Device

Intervention Type DEVICE

PFO device closure

Interventions

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AMPLATZER® PFO Occluder Device

PFO device closure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects who are age 18 to 65
* Subjects who have migraine headaches with aura diagnosed by a doctor
* Subjects who have not responded to or cannot take common migraine preventive medications

Exclusion Criteria

* Subjects with a clinical history of stroke
* Subjects who cannot take aspirin and clopidogrel (Plavix)
* Subjects who are pregnant or desire to become pregnant within the next year
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prima Trial Steering Committee

Role: STUDY_CHAIR

Locations

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University of Calgary- Foothills Hospital

Calgary, Alberta, Canada

Site Status

Alberta Health Services and the University of Alberta

Edmonton, Alberta, Canada

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

University of Ottawa

Ottawa, Ontario, Canada

Site Status

Davisville Medical Center

Toronto, Ontario, Canada

Site Status

Institut de Cardiologie de Montreal

Montreal, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Québec

Québec, Quebec, Canada

Site Status

Unfallkrankenhaus Berlin

Berlin, , Germany

Site Status

Martin-Luther-University Halle-Wittenberg

Halle, , Germany

Site Status

Universitätsklinikum Hamburg

Hamburg, , Germany

Site Status

Neurologisch-verhaltensmedizinische Schmerzklinik Kiel

Kiel, , Germany

Site Status

Universitätsklinikum Münster

Münster, , Germany

Site Status

Swiss Cardiovascular Center Bern

Bern, , Switzerland

Site Status

Kopfwehzentrum Hirslanden Zürich

Zurich, , Switzerland

Site Status

Royal Sussex County Hospital

Brighton, , United Kingdom

Site Status

St. Mary's Hospital Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

South Manchester University Hospital

Manchester, , United Kingdom

Site Status

Countries

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Canada Germany Switzerland United Kingdom

References

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Mattle HP, Evers S, Hildick-Smith D, Becker WJ, Baumgartner H, Chataway J, Gawel M, Gobel H, Heinze A, Horlick E, Malik I, Ray S, Zermansky A, Findling O, Windecker S, Meier B. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial. Eur Heart J. 2016 Jul 7;37(26):2029-36. doi: 10.1093/eurheartj/ehw027. Epub 2016 Feb 22.

Reference Type DERIVED
PMID: 26908949 (View on PubMed)

Other Identifiers

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AGA010E

Identifier Type: -

Identifier Source: org_study_id

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