Feasibility Clinical Study of the Ovalis, Inc. Patent Foramen Ovale (PFO) Closure System in Patients with Cryptogenic Neurologic Events, Migraines, and Decompression Illness

Phase 1

Recruiting

• Conditions: Patients with cryptogenic neurologic events, migraines and decompression illness due to patent foramen ovale; Neurological - Other neurological disorders

• Registration Number: ACTRN12606000407594
• Lead Sponsor: Robust Industries

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Positive for right to left shunting through a patent foramen ovale (PFO). 2. History of transient ischemic attack (TIA) or stroke; or embolism from the right heart to the heft heart; or low oxygenation in the right atrium associated with the right heart not functioning well; or severe decompression illness (scuba diving or flying); or severe migraine headaches unresponsive to migraine medication as determined by a neurologist.

Exclusion Criteria

1.Intra vascular or intra cardiac masses. 2. Atrial Septal defect (ASD) or intraatrial anatomy that would allow continued shunting. 3. History of bleeding disorder, severe renal dysfunction, or hemodynamic instability. 4. Recent myocardial infarction, Transient ischemic attack or Stroke. 5. Head injuries, seizures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse event[At 12 months after the completion of the study]

Secondary Outcome Measures

Name	Time	Method
one[NA]