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Trial registered on ANZCTR


Registration number
ACTRN12606000407594
Ethics application status
Approved
Date submitted
31/08/2006
Date registered
18/09/2006
Date last updated
9/12/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility Clinical Study of the Ovalis, Inc. Patent Foramen Ovale (PFO) Closure System in Patients with Cryptogenic Neurologic Events, Migraines, and Decompression Illness
Scientific title
A feasibility clinical study of the Ovalis,Inc. Patent Foramen Ovale (PFO) Closure System in patients with cryptogenic neurologic events, migraines, and decompression illness due to patent foramen to assess incidence of adverse effects from this procedure.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with cryptogenic neurologic events, migraines and decompression illness due to patent foramen ovale 1374 0
Condition category
Condition code
Neurological 1467 1467 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Patent Foramen Ovale(PFO) Closure System is a delivery system and permanent implant for percutaneous closure of the patent foramen ovale. Percutaneous closure of a patent foramen ovale is a way of closing the foramen ovale without opening up the chest. A small cut or incision is made in the groin area. A narrow tube called a catheter is passed into the incision and into a blood vessel. The catheter contains a special closing device, and this is passed up though the blood vessels to the heart. The closing device is moved into position at the foramen ovale and then released so that it keeps the two tissue flaps together. X-rays and ultrasound will be used during the procedure to evaluate the device placement. The patient will be monitored at one month, six months and twelve months to assess the patients response to the implant.
Intervention code [1] 1337 0
Treatment: Devices
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2029 0
Safety: Incidence of adverse event
Timepoint [1] 2029 0
At 12 months after the completion of the study
Secondary outcome [1] 3511 0
None
Timepoint [1] 3511 0
NA

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1604 0
Commercial sector/Industry
Name [1] 1604 0
Ovalis,Inc
Country [1] 1604 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Robust Industries
Address
95 Stevedore Street
Williamstown,3016,Victoria
Country
Australia
Secondary sponsor category [1] 1409 0
Commercial sector/Industry
Name [1] 1409 0
Ovalis,Inc
Address [1] 1409 0
1920 Old Middlefield Way
Mountain View, CA 94043 USA
Country [1] 1409 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3051 0
Southern Health HREC
Ethics committee address [1] 3051 0
Ethics committee country [1] 3051 0
Australia
Date submitted for ethics approval [1] 3051 0
Approval date [1] 3051 0
Ethics approval number [1] 3051 0

Summary
Brief summary
The purpose of this study is to evaluate the safety and feasibility ofa new Patent Foramen Ovale (PFO) closure device. The foramen ovale is a hole in the wall that divides the two sides of the heart. It’s present in the heart of a developing fetus, but normally it closes up soon after the baby is born. If it doesn’t close up, it’s known as a patent foramen ovale (PFO).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27944 0
Address 27944 0
Country 27944 0
Phone 27944 0
Fax 27944 0
Email 27944 0
Contact person for public queries
Name 10526 0
Ronald Jabba
Address 10526 0
1920 Old Middlefield Way
Mountain View CA 94043
Country 10526 0
United States of America
Phone 10526 0
+1 650 2547600
Fax 10526 0
Email 10526 0
[email protected]
Contact person for scientific queries
Name 1454 0
Professor Ian T Meredith
Address 1454 0
Monash Cardiovascular Research Centre
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 1454 0
Australia
Phone 1454 0
+61 3 959444307
Fax 1454 0
Email 1454 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.