None listed
Conditions
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).
Interventions
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 ultrasou
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.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age >/= 18 years, patent foramen ovale, morbidity suspected of being related to patent foramen ovale
Exclusion criteria
Pregnancy, age <18 years, patent foramen ovale tunnel diameter >4 mm
Outcome results
None listed