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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
RESEARCH DEVELOPMENT OFFICE
ROYAL PRINCE ALFRED HOSPITAL
MISSENDEN ROAD
CAMPERDOWN NSW 2050
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
Background
Patent foramen ovale (PFO) is a communication or “hole” between 2 chambers of the heart – the right and left atria. A PFO is present in approximately 25% of the population. PFOs can cause strokes, decompression illness in divers, and migraine headaches. Doctors sometimes recommend that a PFO should be closed if these problems occur.

The usual technique for closing a PFO is to implant a metal and fabric “plug” known as a “closure device” to seal or plug the PFO. In general this is a safe and effective technique (with a success rate > 95%) but there are some risks and disadvantages with the use of the closure device.

Some of the disadvantages and risks include leaving a foreign object in the body forever, a risk of the device eroding into surrounding tissue occurring in about 1 in 1000 cases (e.g. into a blood vessel or heart valve), a risk of the device dislodging in about 1-3 in 100 cases (which may require urgent open heart surgery), risk of the heart beating very slowly in 1-5 in 100 cases (which may require a pacemaker), risk of clot forming around the closure device in 1-2 in 100 cases (which may lead to stroke), and risk of infection. In addition, the closure device prevents subsequent trans-septal puncture which might be required for treatment of arrhythmias or mitral valve disease should these develop in later life.

We aim to test new technique to close PFOs. This technique aims to close the PFO without the use of a closure device, and may be safer and cheaper. The technique involves the use of electrical current to “glue” the edges of the PFO together. Recent studies report that this new technique is safe and has success rates of up to ~90% of cases in carefully selected patients with PFO tunnel diameter < 4mm (Sievert et al. Circulation 2007; Walpoth et al. Swiss Med Wkly 2008; Sievert et al. Cath Cardiovasc Interv 2009; Di Biase et al. ACC 2010 Abstract). The total number of patients recruited from these 4 studies totalled 200, with only 2 patients suffering from significant blood loss (and only 1 requiring blood transfusion) as a result of this new technique. There were no other serious adverse complications such as stroke or heart perforation reported. The mean procedure time reported in these studies was between 30-50 mins, which is comparable to PFO closure using the standard technique. 3 of these studies (involving 190 patients in total) used a proprietary radiofrequency ablation catheter with vacuum suction, and 1 study (involving 10 patients) used a standard radiofrequency ablation catheter. In addition, because of similar procedure times, the radiation exposure is not anticipated to be higher as a result of the research study. In fact, we anticipate that the calculated X-ray exposure is likely to be less than the current technique for PFO closure.

Aim
We aim to test this new technique for closing the PFO without the use of a closure device.

Potential Significance
This new technique may be safer than PFO closure using the closure device. In addition, it will also be considerably cheaper (approximately $2500-$3000 vs $7500-$9000).
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

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