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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01550588
Recruitment Status : Unknown
Verified June 2017 by Jae-Kwan Song, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : March 12, 2012
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Jae-Kwan Song, Asan Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Patent Foramen Ovale Device: Device closure Drug: Standard medical treatment Phase 4

Detailed Description:

Selection of patients:

Among cryptogenic stroke patients, patients who was identified as high risk PFO which might be defined as high-risk of recurrence (PFO size ≥ 2 mm or atrial septal aneurysm or hypermobility by TEE) will be randomized 1:1 to :a) Device closure using Amplatzer device vs. b) standard medical therapy alone. All patients will be followed for at least 2 years.

Echocardiography Findings for high-risk PFO Digitally, stored transesophageal echocardiographic images were reviewed and analyzed by an investigator. Using calipers, the PFO size was measured as the maximum separation of the septum primum from the septum secundum. ASA or hypermobility was defined as ≥ 10 mm of phasic septal excursion either into the atrium or a sum total excursion of ≥ 15 mm during the cardiorespiratory cycle, with a base of ≥ 15 mm.

Web-based 1:1 blinded randomization for

  • Experimental Percutaneous Device Closure using AMPLATZER PFO Occluder
  • Active Comparator Standard Medical management using anti-coagulant therapy (at least 3 or 6 months) Study Endpoints

  • Primary outcome

    • Recurrence of nonfatal stroke/vascular death/TIMI-major bleeding

  • Secondary outcome

    • Recurrent nonfatal stroke
    • Vascular death
    • Major bleeding associated with medication
    • Asymptomatic recurrent ischemic stroke on follow-up MR
    • Complete closure of the defect demonstrated by TEE and bubble study (device group) Frequency of residual shunt, (in)correct device position, need for implantation of second device and peri-procedural complications
    • Procedure related complications
    • Medication related complications
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Device Closure Versus Medical Therapy for Secondary Prevention in Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale : DEFENSE-PFO
Study Start Date : February 2012
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Medication
Anticoagulation, Antiplatelet agent
 Drug: Standard medical treatment
Standard Medical management using anti-coagulant therapy
Active Comparator: Device closure
Amplatzer PFO occluder device
 Device: Device closure
PFO Amplatzer device closure
Other Name: PFO Amplatzer device


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence of nonfatal stroke / vascular death / TIMI-major bleeding [ Time Frame: 2-year ]

Secondary Outcome Measures :
  1. Recurrent nonfatal stroke [ Time Frame: 2-year ]
  2. Vascular death [ Time Frame: 2-year ]
  3. Major bleeding associated with medication [ Time Frame: 2-year ]
  4. Asymptomatic recurrent ischemic stroke on follow-up MR [ Time Frame: 2-year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550588


Contacts
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Contact: Jae-Kwan Song, MD, PhD (82-2)-3010-3155 jksong@amc.seoul.kr

Locations
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Korea, Republic of
YangSan Busan University Hospital Recruiting
Busan, Korea, Republic of
Contact: Yong-Hyung Park, MD, PhD    82-2-3010-3150    nadroj@chol.com   
Principal Investigator: Yong-Hyun Park, MD, PhD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jae Hwan Lee, Md, PhD    82-3010-3162    myheart@cnu.ac.kr   
Principal Investigator: Jae Hwan Lee, MD, PhD         
Gang Neung Asan Hospital Recruiting
Gangneung, Korea, Republic of
Contact: Sang-Sig Jeong, MD, PhD    82-2-3010-3150    sscheng@gnah.co.kr   
Principal Investigator: Sang-Sig Jeong, MD, PhD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Eun-Seok Shin, Md, PhD    82-3010-3155    jksong@amc.seoul.kr   
Principal Investigator: Eun-Seok Shin, MD, PhD         
Sponsors and Collaborators
Jae-Kwan Song
Investigators
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Principal Investigator: Jae-Kwan Song, MD, PhD Department of medicine, Asan Medical Center, University of Ulsan College of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jae-Kwan Song, professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01550588    
Other Study ID Numbers: 2011-0553
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Keywords provided by Jae-Kwan Song, Asan Medical Center:
PFO
Stroke
Additional relevant MeSH terms:
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Ischemic Stroke
Foramen Ovale, Patent
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities