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A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices
Device: Amplatzer™ Trevisio™ Intravascular Delivery System
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, Amplatzer ASO, Amplatzer Cribriform Occluder, Amplatzer Muscular VSD Occluder, and Amplatzer Post-Infarct Muscular VSD Occluder.
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This clinical study will enroll male and female adults and children with a PFO (adults only), ASD or VSD who are indicated for transcatheter closure. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any study-specific procedures not considered standard of care.
Patient is indicated for implantation with the Amplatzer Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure) OR subject is indicated for implantation with the Amplatzer PFO Occluder OR subject is indicated for implantation with the Amplatzer Muscular VSD Occluder OR subject is indicated for implantation with the Amplatzer Post-Infarct Muscular VSD Occluder
Patient is of legal age and has provided his/her own written, informed consent
Patient is a minor and has provided verbal and/or written informed consent or assent per local EC requirements, and his/her legally authorized representative, or representatives, have provided written informed consent on behalf of the minor according to local EC requirements
Presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Principal Investigator's opinion, could limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.
Exclusion Criteria for Patients Undergoing ASD Closure with the Amplatzer ASO or Amplatzer ASD-MF Occluder
Patients known to have extensive congenital cardiac anomaly that can only be adequately repaired by cardiac surgery
Patients known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement
Patients known to have demonstrated intracardiac thrombus on echocardiography (especially left atrial or left atrial appendage thrombi)
Patients whose size or condition (e.g., too small for transesophageal echocardiography [TEE] probe, catheter size, vasculature size, active infection) would cause the patient to be a poor candidate for cardiac catheterization
Patients with defect margins less than 5 mm to the coronary sinus, inferior vena cava rim, an atrioventricular valve, or the right upper lobe pulmonary vein
Exclusion Criteria for Patients Undergoing PFO Closure
Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained. Thrombus must be ruled out prior to introducing the delivery system.
Active endocarditis or other infections producing bacteremia
Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size
Anatomy in which the Amplatzer™ PFO device size required would interfere with other intra-cardiac or intravascular structures, such as valves or pulmonary veins
Patients with known hypercoagulable states
Patients with intra-cardiac mass or vegetation, thrombus, or tumor
Exclusion Criteria for Patients Undergoing VSD Closure with the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder