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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Device Closure Versus Medical Therapy for Secondary Prevention in Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale : DEFENSE-PFO

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.

Detailed Summary:

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
  • Sponsor: Duk-Woo Park
    

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

    Original Primary Outcome: Same as current
    
    

    Current Secondary Outcome:

    • Recurrent nonfatal stroke [ Time Frame: 2-year ]
    • Vascular death [ Time Frame: 2-year ]
    • Major bleeding associated with medication [ Time Frame: 2-year ]
    • Asymptomatic recurrent ischemic stroke on follow-up MR [ Time Frame: 2-year ]
    
    
    

    Original Secondary Outcome: Same as current
    
    Information By: CardioVascular Research Foundation, Korea
    

    Dates:
    Date Received: February 26, 2012
    Date Started: February 2012
    Date Completion: February 2017
    Last Updated: August 8, 2012
    Last Verified: August 2012