Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale (DEFENSE-PFO)
1 other identifier
interventional
210
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2012
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 26, 2012
CompletedFirst Posted
Study publicly available on registry
March 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedJune 29, 2017
June 1, 2017
8 years
February 26, 2012
June 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence of nonfatal stroke / vascular death / TIMI-major bleeding
2-year
Secondary Outcomes (4)
Recurrent nonfatal stroke
2-year
Vascular death
2-year
Major bleeding associated with medication
2-year
Asymptomatic recurrent ischemic stroke on follow-up MR
2-year
Study Arms (2)
Medication
PLACEBO COMPARATORAnticoagulation, Antiplatelet agent
Device closure
ACTIVE COMPARATORAmplatzer PFO occluder device
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jae-Kwan Songlead
Study Sites (4)
YangSan Busan University Hospital
Busan, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Gang Neung Asan Hospital
Gangneung, South Korea
Ulsan University Hospital
Ulsan, South Korea
Related Publications (2)
Turc G, Lee JY, Brochet E, Kim JS, Song JK, Mas JL; CLOSE and DEFENSE-PFO Trial Investigators. Atrial Septal Aneurysm, Shunt Size, and Recurrent Stroke Risk in Patients With Patent Foramen Ovale. J Am Coll Cardiol. 2020 May 12;75(18):2312-2320. doi: 10.1016/j.jacc.2020.02.068.
PMID: 32381162DERIVEDLee PH, Song JK, Kim JS, Heo R, Lee S, Kim DH, Song JM, Kang DH, Kwon SU, Kang DW, Lee D, Kwon HS, Yun SC, Sun BJ, Park JH, Lee JH, Jeong HS, Song HJ, Kim J, Park SJ. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial. J Am Coll Cardiol. 2018 May 22;71(20):2335-2342. doi: 10.1016/j.jacc.2018.02.046. Epub 2018 Mar 12.
PMID: 29544871DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-Kwan Song, MD, PhD
Department of medicine, Asan Medical Center, University of Ulsan College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
February 26, 2012
First Posted
March 12, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
June 29, 2017
Record last verified: 2017-06