Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000184077
Ethics application status
Approved
Date submitted
20/02/2010
Date registered
2/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Coherex-PFO-Sleep Hypoxia: A multi-center study to determine the response to closure of patent foramen ovale (PFO) with the Coherex FlatStentTM EF PFO Closure System (EF is part of the trade mark name and stands for Enhanced Foam) in patients diagnosed with PFO and significant oxygen desaturation in obstructive sleep apnea (OSA)
Scientific title
A feasibility study of 30-50 patients to evaluate the clinical response to Patent Foramen Ovale (PFO) closure using Coherex FlatStentTM EF PFO Closure System (EF is part of the trade mark name and stands for Enhanced Foam) in Obstructive Sleep Apnea (OSA) patients with significant right-to-left shunting and oxygen desaturation as demonstrated during sleep studies.
Secondary ID [1] 1451 0
None
Universal Trial Number (UTN)
Trial acronym
COHEREX-PFO-SLEEP-HYPOXIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Significant oxygen desaturation associated with right-to-left shunts through a PFO in Obstructive Sleep Apnea(OSA) patients 256860 0
Condition category
Condition code
Cardiovascular 257008 257008 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coherex FlatStentTM EF Patent Foramen Ovale (PFO) Closure System is a permanent implant placed percutaneously by an interventional cardiologist into a patent foramen ovale to close the congenital defect. The procedure takes approximately 30 minutes. Patients will be observed for 6 months after the permanent device placement.
Intervention code [1] 256056 0
Treatment: Devices
Comparator / control treatment
No Comparator. This is a registry feasibility study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257905 0
Primary outcome will be measured by the percentage of high-risk OSA patients enrolled in the study with a right-to-left shunt whose oxygen desaturation index demonstrates improvement during polysomnogram (PSG) after PFO closure.
Timepoint [1] 257905 0
A polysomnogram (PSG) will be done at 90 days post procedure if PFO is confirmed closed by transcranial doppler (TCD). If not closed, a PSG will be done at 180 days post procedure
Secondary outcome [1] 263369 0
Adverse events at 90 days post intervention
This will include observed or self reported events that are adverse changes in the patients baseline health status. All adverse events will be recorded in the patient file.

Possible adverse effects include, but are not limited to:Death, Acute myocardial infarction, Air, tissue, or thrombotic embolization, Hemorrhage or hematoma, Stroke/cerebrovascular accident or transient ischemic attacks, Arrhythmias, including ventricular fibrillation and ventricular tachycardia, Drug reactions, allergic reaction to contrast media or device components, Device embolization or migration, Amputation, Endocarditis, Cardiac tissue trauma, Renal insufficiency, kidney failure, Bleeding complications requiring transfusion, Hypotension/hypertension, Damage to implanted stent, Patient infection, Vessel spasm, Vessel dissection
Timepoint [1] 263369 0
Patient follow up at 90 days post-intervention
Secondary outcome [2] 263370 0
Improvement of right to left shunt and rates of closure of the PFO as assessed by contrast transesophogeal echocardiography(view of the heart through the esophagus using ultrasound).
Timepoint [2] 263370 0
Patient follow up at 90 and 180 days post-intervention

Eligibility
Key inclusion criteria
Diagnosis of OSA and a polysomnogram within the past year that demonstrated an apnea index > 20 seconds (AI20) of greater than 5 and an oxygen desaturation index > 6% (ODI6) of greater than 5 associated with apnic events. Patients willing to under go transcranial doppler (TCD) and demonstrates a Grade IV or Grade V right-to-left shunt. Patients must demonstrate a PFO amenable to transcatheter closure with the Coherex FlatStentTM EF PFO Closure System.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Candidates will be excluded from the study if ANY of the following conditions apply: 1. Long-term requirement for anti-platelet therapy, anticoagulation, or coagulopathy. 2. Contraindication and/or allergy to aspirin, clopidogrel, Nitinol, Dacron, polyurethane, nickel, stainless steel or other stent materials. 3. Concurrent enrollment in another clinical study. 4. Body mass index > 40. 5. Botox treatment within the past 90 days. 6. Other known structural heart disease, coronary artery disease, or atrial fibrillation. 7. Chronic liver disease, kidney disease, or organ failure. 8. Auto-immune disease. 9. Psychiatric illness, which in the investigator’s opinion, will interfere with completion of the study. 10. Degenerative neurologic disorders. 11. Any known active bacterial infection. 12. Malignancy or other illness with a life expectancy less than two years. 13. Pregnancy or desire to become pregnant during course of study. 14. Right-to-left shunt besides PFO detected prior to enrollment. 15.Uncontrolled hypertension defined as blood pressure greater than140/90 mmHg. 16. Immunosuppressive therapy. 17.Diabetes requiring insulin or blood glucose greater than 200 mg/deciliter on oral diabetic medications. 18. Concomitant pulmonary disorder (chronic obstructive pulmonary disorder [COPD], asthma, etc.) requiring treatment. 19. Any medical disorder that would interfere with study completion. 20. Known severe pulmonary hypertension (requiring medication). 21.Patients who have had a major stroke within the past two months or a minor stroke within the past two weeks (see National Institutes of Health (NIH) Stroke Scale). 22. Patients who require a transseptal puncture to access the left atrium. 23. Patients with known sustained arrhythmia.

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
Persons with OSA referred to investigators for PFO closure who meet inclusion/exclusion criteria will be invited to participate and be enrolled if the PFO size is appropriate for the use of the Coherex FlatStentTM EF PFO Closure System
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2501 0
New Zealand
State/province [1] 2501 0
Auckland
Country [2] 2502 0
Germany
State/province [2] 2502 0
Frankfurt
Country [3] 2503 0
France
State/province [3] 2503 0
Paris

Funding & Sponsors
Funding source category [1] 256560 0
Commercial sector/Industry
Name [1] 256560 0
Coherex Medical Inc.
Country [1] 256560 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Coherex Medical Inc.
Address
3598 West 1820 South Salt Lake City, UT 84104
Country
United States of America
Secondary sponsor category [1] 255855 0
None
Name [1] 255855 0
Address [1] 255855 0
Country [1] 255855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258597 0
Freiburger Ethik-Kommission International
Ethics committee address [1] 258597 0
Mozartstrasse 21 79104 Freiburg
Ethics committee country [1] 258597 0
Germany
Date submitted for ethics approval [1] 258597 0
12/01/2009
Approval date [1] 258597 0
06/03/2009
Ethics approval number [1] 258597 0
None

Summary
Brief summary
The Coherex-PFO-Sleep Hypoxia is a multi-center study for up to 50 patients to determine the response to closure of patent foramen ovale (PFO) with the Coherex FlatStentTM EF PFO Closure System in patients diagnosed with PFO and significant oxygen desaturation in obstructive sleep apnea (OSA)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30865 0
Address 30865 0
Country 30865 0
Phone 30865 0
Fax 30865 0
Email 30865 0
Contact person for public queries
Name 14112 0
Randall K. Jones MD
Address 14112 0
3598 West 1820 South
Salt Lake City, Utah 84104
Country 14112 0
United States of America
Phone 14112 0
+1 (801) 433-9900
Fax 14112 0
+1 (801) 433-9901
Email 14112 0
[email protected]
Contact person for scientific queries
Name 5040 0
Randall K. Jones MD
Address 5040 0
3598 West 1820 South
Salt Lake City, Utah 84104
Country 5040 0
United States of America
Phone 5040 0
+1 (801) 433-9900
Fax 5040 0
+1 (801) 433-9901
Email 5040 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

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