Abbott developed the AMPLATZER™ PFO Occluder as a minimally invasive, transcatheter PFO closure treatment to further reduce the risk of recurrent stroke among patients with PFO and cryptogenic stroke beyond that achieved with medical management. This additional risk reduction is achieved by blocking the pathway for a venous embolism from reaching the body's arterial system and the brain.
The safety and effectiveness of the AMPLATZER™ PFO Occluder was evaluated in RESPECT, a randomized controlled clinical trial conducted under an investigational device exemption (IDE), which was the largest trial of a transcatheter PFO closure device, with the longest follow-up. RESPECT demonstrated that the AMPLATZER™ PFO Occluder is effective in reducing recurrent ischemic stroke in subjects implanted with the device and can be implanted safely. The AMPLATZER™ PFO Occluder received market approval by FDA on October 28, 2016.
The purpose of this study is the continued evaluation of the long-term safety and effectiveness of the AMPLATZER™ PFO Occluder in a post approval setting.
To participate in this clinical study, the subject must meet all of the following inclusion criteria:
- Subjects with a PFO who have had an ischemic stroke within the last 270 days, have undergone investigation by a neurologist to exclude known causes of ischemic stroke, and have therefore been determined to have had a cryptogenic stroke (i.e., stroke from an unknown causes) assessed by a neurologist within the last 270 days, with stroke defined as follows: acute focal neurological deficit, presumed to be due to focal ischemic, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT findings of a new, neuroanatomically relevant, cerebral infarct.
- Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter.
- Unable to take antiplatlet therapy.
- Anatomy in which AMPLAZTER™ PFO Occduler device required would interfere with intracardiac or intravascular structures such as valves or pulmonary veins.
Enrolled subjects will undergo a percutaneous, transcatheter closure procedure with the AMPLATZER™
PFO Occluder device. After discharge from hospitalization post procedure, the subject will have a follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant. This follow-up schedule is standard of care. Upon completion of the 5 year follow-up visit, the subject will be considered to have completed the follow-up requirements of this clinical study. The Principal Investigator should arrange for appropriate care of subjects following study completion.