RESPECT PFO Clinical Trial

Active, not recruiting

Phase 2 Results N/A

Trial Description

The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.

Detailed Description

The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke due to presumed paradoxical embolism within the last 270 days.

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Clopidogrel (Plavix®)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Dipyridamole (Persantine®)Drug
    Intervention Desc: Platelet aggregation inhibitor
  • Warfarin (Coumadin®)Drug
    Other Names: Coumadin; Acenocoumarol
    Intervention Desc: Anticoagulant (Vitamin K antagonist)
  • AMPLATZER PFO Occluder Device
    Intervention Desc: patent foramen ovale closure device
    ARM 1: Kind: Experimental
    Label: 1
    Description: AMPLATZER PFO Occluder
    ARM 2: Kind: Experimental
    Label: Device
    Description: AMPLATZER PFO Occluder
  • Standard of Care - Medical Management Other
    Intervention Desc: Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
    ARM 1: Kind: Experimental
    Label: 2
    Description: Medical Management
    ARM 2: Kind: Experimental
    Label: Standard or Care - Medical Management
    Description: Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients are randomly assigned to best medical therapy or PFO closure with the AMPLATZER PFO Occluder. Best medical therapy treatment options include aspirin alone, Coumadin alone, clopidogrel alone, or aspirin combined with dipyridamole.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary endpoint is recurrence of non-fatal stroke, post-randomization mortality, or fatal ischemic stroke.
Secondary The secondary endpoints are complete closure of the defect at the six-month follow-up, absence of recurrent symptomatic cryptogenic nonfatal stroke or cardiovascular death, and occurrence of TIA.
Primary Recurrence of nonfatal stroke Annually until approved No
Secondary Complete closure of the defect demonstrated by TEE and bubble study (device group). 6 months No

Sponsors