PRIMA PFO Migraine Trial | NCT00505570

Studies
PRIMA PFO Migraine Trial

NCT00505570

Sponsor

Abbott Medical Devices

Status

Terminated

Last Update Posted

Feb 4, 2019Actual

Enrollment

107Actual

Phase

Phase 2

Conditions

Migraine
Migraine With Aura
Patent Foramen Ovale
PFO

Interventions

AMPLATZER® PFO Occluder Device

Countries

Canada
Germany
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Jul 20, 2007

First Submission Date that Met QC Criteria

Jul 20, 2007

First Posted Date

Jul 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medical Management	No Intervention
PFO Closure	Experimental		Device: AMPLATZER® PFO Occluder Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AMPLATZER® PFO Occluder Device	Device	PFO device closure	PFO Closure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Migraine headache frequency		12 months

Secondary Outcomes

Measure	Description	Time Frame
Responder rate; Acute migraine medication use; Quality of life evaluations; Effects of Anti-thrombotic medications; Adverse events; PFO Closure		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prima Trial Steering Committee		Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Calgary- Foothills Hospital		Calgary	Alberta	T2N 2T9	Canada
Alberta Health Services and the University of Alberta

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26908949	Derived	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.

ID	Term
D008881	Migraine Disorders
D020325	Migraine with Aura
D054092	Foramen Ovale, Patent

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases