Amplatzer™ Trevisio™ Delivery System Post-Approval Study (Trevisio PAS)

STATUS

Recruiting
End date

Oct 15, 2025
participants needed

254
sponsor

Abbott Medical Devices

Updated on 10 October 2022

See if I qualify

septal defect

atrial septal defect

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

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.

Details

Condition	PFO - Patent Foramen Ovale, ASD - Atrial Septum Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
Treatment	Amplatzer™ Trevisio™ Intravascular Delivery System, Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, Amplatzer ASO or Amplatzer Cribriform Occluder, Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
Clinical Study Identifier	NCT04433520
Sponsor	Abbott Medical Devices
Last Modified on	10 October 2022

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Eligibility		Yes	No	Not Sure
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
	Exclusion Criteria for Patients Undergoing PFO Closure
	Patients known to have sepsis within 1 month prior to implantation, or any
	Active endocarditis or other infections producing bacteremia
	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 with known hypercoagulable states
	Patients whose size or condition (e.g., too small for transesophageal
	Patients with intra-cardiac mass or vegetation, thrombus, or tumor
	echocardiography [TEE] probe, catheter size, vasculature size, active infection)
	would cause the patient to be a poor candidate for cardiac catheterization
	Body weight <8 kg
	Patients with defect margins less than 5 mm to the coronary sinus, inferior vena
	Tetralogy of Fallot
	cava rim, an atrioventricular valve, or the right upper lobe pulmonary vein
	Intracardiac thrombi on echocardiography
	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
	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
	Exclusion Criteria for Patients Undergoing VSD Closure with the Amplatzer Muscular VSD
	Occluder or Amplatzer Post-Infarct Muscular VSD Occluder

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Amplatzer™ Trevisio™ Delivery System Post-Approval Study (Trevisio PAS)