Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000225718
Ethics application status
Not yet submitted
Date submitted
20/02/2013
Date registered
25/02/2013
Date last updated
25/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Percutaneous closure of patent foramen ovale using radiofrequency energy
Scientific title
Feasibility study of percutaneous closure of patent foramen ovale using radiofrequency energy in patients suffering from complications of patent foramen ovale
Secondary ID [1] 281990 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patent foramen ovale 288422 0
Stroke 288423 0
Migraine 288424 0
Decompression sickness 288425 0
Condition category
Condition code
Cardiovascular 288773 288773 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Percutaneous closure of patent foramen ovale using standard radiofrequency ablation catheter rather than standard closure using an occluder device. This procedure is very similar to the standard technique in which the hole in the heart is closed with a plug-like device.

You will be admitted to hospital on the morning of the procedure. The procedure should take less than an hour, which is possibly shorter than the standard procedure, and will be performed under general anaesthetic. An ultrasound tube will be inserted through your mouth and into your oesophagus (food pipe). (This procedure is known as transoesophageal echocardiogram). A short tube will be inserted into the vein in your groin. A catheter (a longer tube) will then be advanced through the vein from your groin to the PFO in your heart. This will be performed under X-ray and ultrasound guidance. The only difference with this new procedure is that at this point in the operation, instead of using a plug to close the hole, we will use radiofrequency energy to “seal” or “weld” the hole closed.

All the tubes will then be removed, and local anaesthetic injected into your groin to make sure you are comfortable after the procedure. A nurse will press on your groin for about 15 minutes to stop any bleeding, and you will be asked to lie flat for the next 2 hours to avoid any groin bleeding.

You will remain in hospital overnight, and undergo an ultrasound of your heart the next morning before being discharged.

You will be asked to come to the hospital for a check-up 6 weeks after the procedure. During this visit you will undergo another transoesophageal echocardiogram to ensure that the hole was successfully sealed. This will be performed under mild intravenous sedation.
Intervention code [1] 286559 0
Treatment: Devices
Comparator / control treatment
Historical controls using standard occluder device for patent foramen ovale closure. This will be a retrospective analysis of all patent foramen ovale closures performed at the Department of Cardiology, Royal Prince Alfred Hospital from 1999 - current.
Control group
Historical

Outcomes
Primary outcome [1] 288909 0
Closure of patent foramen ovale. This will be assessed by transesophageal echocardiogram performed 6 weeks post procedure.
Timepoint [1] 288909 0
6 weeks
Secondary outcome [1] 301309 0
Safety of procedure. Complications monitored for include significant bleeding post procedure, stroke, heart attack, heart perforation and death.
Timepoint [1] 301309 0
0-6 weeks

Eligibility
Key inclusion criteria
Age >/= 18 years, patent foramen ovale, morbidity suspected of being related to patent foramen ovale
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, age <18 years, patent foramen ovale tunnel diameter >4 mm

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
N/A

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 633 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 6365 0
2050 - Missenden Road

Funding & Sponsors
Funding source category [1] 286768 0
Hospital
Name [1] 286768 0
Royal Prince Alfred Hospital, Department of Cardiology Trust Fund
Country [1] 286768 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 285548 0
None
Name [1] 285548 0
Address [1] 285548 0
Country [1] 285548 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288834 0
Sydney Local Heath District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 288834 0
Ethics committee country [1] 288834 0
Australia
Date submitted for ethics approval [1] 288834 0
22/10/2012
Approval date [1] 288834 0
Ethics approval number [1] 288834 0
12/RPAH/544

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37470 0
A/Prof Mark McGuire
Address 37470 0
Suite 204
RPAH Medical Centre
100 Carillon Avenue
Newtown NSW 2042
Country 37470 0
Australia
Phone 37470 0
+61 2 95195922
Fax 37470 0
+61 2 95195944
Email 37470 0
[email protected]
Contact person for public queries
Name 37471 0
Mark McGuire
Address 37471 0
Suite 204
RPAH Medical Centre
100 Carillon Avenue
Newtown NSW 2042
Country 37471 0
Australia
Phone 37471 0
+61 2 95195922
Fax 37471 0
+61 2 95195944
Email 37471 0
[email protected]
Contact person for scientific queries
Name 37472 0
Mark McGuire
Address 37472 0
Suite 204
RPAH Medical Centre
100 Carillon Avenue
Newtown NSW 2042
Country 37472 0
Australia
Phone 37472 0
+61 2 95195922
Fax 37472 0
+61 2 95195944
Email 37472 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.