PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness

The Paradigm IV Trial - PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00529945

Acronym

Paradigm IV

Enrollment

200

Registered

2007-09-14

Start date

2007-08-31

Completion date

2007-12-31

Last updated

2007-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decompression Illness, Migraine, PFO, Stroke, Transient Ischemic Attack

Keywords

PFO, Stroke, Transient Ischemic Attack, Migraine, Decompression Illness

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.

Interventions

DEVICEPFx Closure System

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* In appropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.

Design outcomes

Primary

Measure	Time frame
PFO closure at 6 months post procedure.	6 months post procedure

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026