Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale (DEFENSE-PFO)

• Status: Unknown status
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Background and hypothesis:

The appropriate treatment strategy for secondary stroke prevention in patients with cryptogenic stroke and patent foramen ovale (PFO) remains challenging. Clinical and anatomical variables reported to be risk factors associated with stroke recurrence include older age, large PFO, large right-to-left shunting, and combined atrial septal aneurysm (ASA), which, however, were not confirmed by other studies. The investigators hypothesized that percutaneous closure of PFO could be an effective option for secondary prevention in cryptogenic stroke patients with high-risk PFO.

Trial Objective:

The primary objective of this study is to assess whether percutaneous device closure of PFO is superior to conventional antithrombotic treatment in preventing stroke recurrence in the cryptogenic stroke patients with high-risk PFO.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jae-Kwan Song

Criteria

Inclusion Criteria:

• Subjects who have had a cryptogenic stroke within the previous 3 months, radiologically verified

• Subjects who have been diagnosed with a high-risk* Patent Foramen Ovale (PFO), echocardiographically verified (*PFO size ≥ 2 mm or atrial septal aneurysm or hypermobility by TEE)

• Subjects willing to participate in follow-up visits

• Absence of other potential causes of stroke

Exclusion Criteria:

• Any identifiable cause of thromboembolic cause other than PFO

• Subjects with intracardiac thrombus or tumor, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis

• Subjects with significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis and coagulopathy

• Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina

• Subjects who have a non-vascular origin of the neurological symptoms after brain imaging (CT scan or MRI)

• History of intracranial bleeding, confirmed arterio-venous malformation,aneurysm or uncontrolled coagulopathy

• Pre-existing neurological disorders or intracranial disease, e.g. multiple sclerosis

• Subjects with left ventricular aneurysm or akinesis

• Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)

• Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum

• Subjects who could not undergo the TEE examination

• Subjects with contraindication to aspirin or Clopidogrel therapy

• Pregnant or desire to become pregnant within the next year

• Subjects who have a underlying malignancy