None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety and feasibility ofa new Patent Foramen Ovale (PFO) closure device. The foramen ovale is a hole in the wall that divides the two sides of the heart. It’s present in the heart of a developing fetus, but normally it closes up soon after the baby is born. If it doesn’t close up, it’s known as a patent foramen ovale (PFO).
Interventions
The Patent Foramen Ovale(PFO) Closure System is a delivery system and permanent implant for percutaneous closure of the patent foramen ovale. Percutaneous closure of a patent foramen ovale is a way of closing the foramen ovale without opening up the chest. A small cut or incision is made in the groin area. A narrow tube called a catheter is passed into the incision and into a blood vessel. The catheter contains a special closing device, and this is passed up though the blood vessels to the heart
The Patent Foramen Ovale(PFO) Closure System is a delivery system and permanent implant for percutaneous closure of the patent foramen ovale. Percutaneous closure of a patent foramen ovale is a way of closing the foramen ovale without opening up the chest. A small cut or incision is made in the groin area. A narrow tube called a catheter is passed into the incision and into a blood vessel. The catheter contains a special closing device, and this is passed up though the blood vessels to the heart. The closing device is moved into position at the foramen ovale and then released so that it keeps the two tissue flaps together. X-rays and ultrasound will be used during the procedure to evaluate the device placement. The patient will be monitored at one month, six months and twelve months to assess the patients response to the implant.
Sponsors
Robust Industries
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 65 Years
Healthy volunteers
No
Inclusion criteria
1. Positive for right to left shunting through a patent foramen ovale (PFO). 2. History of transient ischemic attack (TIA) or stroke; or embolism from the right heart to the heft heart; or low oxygenation in the right atrium associated with the right heart not functioning well; or severe decompression illness (scuba diving or flying); or severe migraine headaches unresponsive to migraine medication as determined by a neurologist.
Exclusion criteria
1.Intra vascular or intra cardiac masses. 2. Atrial Septal defect (ASD) or intraatrial anatomy that would allow continued shunting. 3. History of bleeding disorder, severe renal dysfunction, or hemodynamic instability. 4. Recent myocardial infarction, Transient ischemic attack or Stroke. 5. Head injuries, seizures.
Outcome results
None listed