ANZCTR - Registration

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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]

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

Stroke

Migraine

Decompression sickness

Condition category

Condition code

Cardiovascular

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]

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]

Closure of patent foramen ovale. This will be assessed by transesophageal echocardiogram performed 6 weeks post procedure.

Timepoint [1]

6 weeks

Secondary outcome [1]

Safety of procedure. Complications monitored for include significant bleeding post procedure, stroke, heart attack, heart perforation and death.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment postcode(s) [1]

2050 - Missenden Road

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Prince Alfred Hospital, Department of Cardiology Trust Fund

Address [1]

Missenden Road
Camperdown NSW 2050

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Prince Alfred Hospital

Address

Missenden Road
Camperdown NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Sydney Local Heath District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

RESEARCH DEVELOPMENT OFFICE
ROYAL PRINCE ALFRED HOSPITAL
MISSENDEN ROAD
CAMPERDOWN  NSW  2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/10/2012

Approval date [1]

Ethics approval number [1]

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

A/Prof Mark McGuire

Address

Suite 204
RPAH Medical Centre
100 Carillon Avenue
Newtown NSW 2042

Country

Australia

Phone

+61 2 95195922

Fax

+61 2 95195944

mark.mcguire@email.cs.nsw.gov.au

Contact person for public queries

Name

Mark McGuire

Address

Suite 204
RPAH Medical Centre
100 Carillon Avenue
Newtown NSW 2042

Country

Australia

Phone

+61 2 95195922

Fax

+61 2 95195944

mark.mcguire@email.cs.nsw.gov.au

Contact person for scientific queries

Name

Mark McGuire

Address

Suite 204
RPAH Medical Centre
100 Carillon Avenue
Newtown NSW 2042

Country

Australia

Phone

+61 2 95195922

Fax

+61 2 95195944

mark.mcguire@email.cs.nsw.gov.au

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.

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