Amplatzer™Trevisio™Delivery System Post-Approval Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 254
- Locations
- 22
- Primary Endpoint
- Effectiveness Endpoint: Rate of Technical Success
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient was 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 was indicated for implantation with the Amplatzer PFO Occluder
- •Patient was of legal age and has provided his/her own written, informed consent
- •Patient was 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, had provided written informed consent on behalf of the minor according to local EC requirements
- •Patient was indicated for implantation with the Amplatzer Muscular VSD Occluder OR patient was indicated for implantation with the Amplatzer Post-Infarct Muscular VSD Occluder
Exclusion Criteria
- •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
- •Body weight <8 kg
- •Tetralogy of Fallot
- •Intracardiac thrombi on echocardiography
Arms & Interventions
ASD/PFO cohort
Subjects indicated for atrial septal defect (ASD) closure with either the ASO or ASD-MF devices as well as subjects indicated for patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder.
The Amplatzer Trevisio Delivery System is to be used for facilitating percutaneous, transcatheter implantation of the occluders.
Intervention: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder (Device)
VSD cohort
Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.
Intervention: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder (Device)
Outcomes
Primary Outcomes
Effectiveness Endpoint: Rate of Technical Success
Time Frame: at pre-hospital discharge or 7 days after the procedure
The Technical success, defined as successful deployment and release of at least one device
Safety Endpoint : Device- or Procedure-related Serious Adverse Events.
Time Frame: through discharge or 7 days after the procedure
The primary safety endpoint is device- or procedure-related serious adverse events through discharge or 7 days, whichever is earlier, including: * Cardiac perforation * Sustained atrial fibrillation requiring intervention * Device thrombus * Device erosion * Device embolization * Vascular complication requiring surgical intervention * Device- or procedure-related serious adverse event leading to death
Secondary Outcomes
No secondary outcomes reported