NCT00335296

Brief Summary

The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

Trial Health

37
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Geographic Reach
3 countries

4 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 24, 2007

Status Verified

December 1, 2007

First QC Date

June 8, 2006

Last Update Submit

December 18, 2007

Conditions

Patent Foramen Ovale

Keywords

PFOMigraineStrokeTIA (transient ischemic attack)Decompression Illness

Outcome Measures

Primary Outcomes (1)

  • PFO closure 6 months post procedure

    6 months

Secondary Outcomes (3)

  • PFO closure at 30 days and 12 months post procedure

    30 days, 12 months

  • AE event rates for all subjects

    30 days, 6 and 12 months

  • Migraine severity

    6 and 12 months

Interventions

PFx catheterDEVICE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years old
  • Documented PFO
  • Subjects with one or more of the following:cryptogenic stroke, transient ischemic attack, embolism, migraine headaches, decompression illness

You may not qualify if:

  • Inappropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

AZ Middleheim Hospital

Antwerp, Belgium

Location

Institut Hospitalier Jacques Carter

Massy, France

Location

Bichat Hospital

Paris, 75877, France

Location

Cardiovascular Center Frankfurt Sankt katharinen

Frankfurt, 60389, Germany

Location

MeSH Terms

Conditions

Foramen Ovale, PatentMigraine DisordersStrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebrovascular DisordersVascular DiseasesBrain Ischemia

Study Officials

  • Alec Vahanian, MD

    Bichat Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 9, 2006

Study Start

May 1, 2006

Study Completion

December 1, 2007

Last Updated

December 24, 2007

Record last verified: 2007-12

Locations

BE(1)FR(2)DE(1)