Trevisio Post-Approval Study

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

Detailed Description
-----------------
The Trevisio PAS study will evaluate the safety and effectiveness of the Amplatzer Trevisio Delivery System for facilitating percutaneous, transcatheter implantation of the following Amplatzer Occluder devices: Amplatzer PFO Occluder, Amplatzer Septal Occluder (ASO), Amplatzer Multi-Fenestrated Septal Occluder Cribriform (ASD-MF), Amplatzer Muscular VSD Occluder (MuscVSD), and Amplatzer Post-Infarct Muscular VSD Occluder (PIVSD). Trevisio PAS has two separate cohorts. The ASD/PFO cohort will comprise 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 VSD cohort will comprise subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.

Official Title
-----------------
Amplatzer™ Trevisio™ Delivery System Post-Approval Study

Conditions
-----------------
PFO - Patent Foramen Ovale, ASD - Atrial Septum Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect

Intervention / Treatment
-----------------
* Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, Amplatzer ASO or Amplatzer Cribriform Occluder
* Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria 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 OR 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 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 Exclusion Criteria for Patients Undergoing VSD Closure with the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder Body weight <8 kg Tetralogy of Fallot Intracardiac thrombi on echocardiography
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASD/PFO cohort<br>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. | Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, Amplatzer ASO or Amplatzer Cribriform Occluder<br>* Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, Amplatzer ASO or Amplatzer Cribriform Occluder.<br>|
| VSD cohort<br>Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders. | Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder<br>* Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success -successful deployment and release of at least one device |  | 5years | 
| Device- or procedure-related serious adverse events through discharge or 7 days, whichever occurs first | Includes: 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 | 5years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ABT-CIP_10319, Amplatzer Trevisio Intravascular Delivery System, Amplatzer Occluder devices