NCT00529945

Brief Summary

The primary object of this study is to demonstrate the continued 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

33
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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

August 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

First QC Date

September 12, 2007

Last Update Submit

December 18, 2007

Conditions

PFOStrokeTransient Ischemic AttackMigraineDecompression Illness

Keywords

PFOStrokeTransient Ischemic AttackMigraineDecompression Illness

Outcome Measures

Primary Outcomes (1)

  • PFO closure at 6 months post procedure.

    6 months post procedure

Secondary Outcomes (1)

  • PFO closure at 30 days and 12 months post procedure. AE event rate for all subjects. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine.

    30 days; 6 and 12 months

Interventions

PFx Closure SystemDEVICE

Eligibility Criteria

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

You may qualify if:

  • Age 18 to 65 years old
  • PFO with one or more of:
  • Cryptogenic stroke,
  • TIA or embolism,
  • History of severe migraine headaches, or
  • History of severe decompression illness.

You may not qualify if:

  • In appropriate 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 (1)

Cardiovascular Center Frankfurt Sankt katharinen

Frankfurt, 60389, Germany

Location

MeSH Terms

Conditions

StrokeIschemic Attack, TransientMigraine Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaHeadache Disorders, PrimaryHeadache Disorders

Study Officials

  • Horst Sievert, MD

    Cardiovascular Center Frankfurt, Germany

    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

September 12, 2007

First Posted

September 14, 2007

Study Start

August 1, 2007

Study Completion

December 1, 2007

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations

DE(1)