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

Cierra200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

PFO Stroke Transient Ischemic Attack Migraine Decompression Illness

Interventions

PFx Closure SystemDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cardiovascular Center Frankfurt Sankt katharinen

Frankfurt, Germany

Outcomes

Primary Outcomes

PFO closure at 6 months post procedure.

Time frame: 6 months post procedure

Secondary Outcomes

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.

Time frame: 30 days; 6 and 12 months

Data from ClinicalTrials.gov

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