Trevisio Post-Approval Study (TrevisioPAS)

Amplatzer™Trevisio™Delivery System Post-Approval Study

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 Overview

• Status: Completed
• Conditions: PFO - Patent Foramen Ovale; VSD - Muscular Ventricular Septal Defect; PIVSD - Post Infarct Muscular Ventricular Septal Defect; ASD - Atrial Septal Defect
• Intervention / Treatment: Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder; Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder

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.

• Study Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

Study Locations

• France
  • Chambray-lès-Tours, France, 37170
    • CHU Trousseau
  • Clermont-Ferrand, France, 63003
    • CHU Gabriel MONTPIED
  • Le Plessis-Robinson, France, 92350
    • Centre Médico Chirurgical Marie Lannelongue
  • Lille, France, 59037
    • Chru Lille
  • Marseille, France, 13005
    • Hopital d'adulte de la Timone
  • Nantes, France, 44093
    • CHU Hopital G. & R. Laënnec
  • Pessac, France, 33604
    • Hôpital Haut Lévêque
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum NRW
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • München, Germany, 80636
    • Deutsches Herzzentrum München des Freistaates Bayern
• Italy
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Monaldi
  • San Donato Milanese, Italy, 20097
    • Policlinico San Donato
  • Tuscany
    • Massa, Tuscany, Italy, 54100
      • Fondazione Toscana Gabriele Monasterio Via Aurelia Sud
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam Academic Medical Centre (AMC)
• Poland
  • Gdansk, Poland, 80-952
    • Uniwersytekie Centrum Kliniczne
  • Warsaw, Poland, 04-628
    • The Cardinal Stefan Wyszynski Institute of Cardiology
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-635
      • Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca ul.
• Spain
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofía
  • Madrid, Spain, 28046
    • Hospital Universitario de La Paz
  • Madrid, Spain, 28046
    • Hospital Universitario de la Paz - Pediatrico
• Switzerland
  • Zurich, Switzerland, 8063
    • Stadtspital Triemli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria

1. 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

2. Patient was of legal age and has provided his/her own written, informed consent

   OR

   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

3. 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

1. 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.

2. 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

3. 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
4. Body weight <8 kg
5. Tetralogy of Fallot
6. Intracardiac thrombi on echocardiography

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VSD cohort; 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; Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder.
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.	Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder; Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness Endpoint: Rate of Technical Success	The Technical success, defined as successful deployment and release of at least one device	at pre-hospital discharge or 7 days after the procedure
Safety Endpoint : Device- or Procedure-related Serious Adverse Events.	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	through discharge or 7 days after the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive Endpoints	The number of times the device is recaptured; The number of times the device is repositioned; Total fluoroscopy time; Ease of use - investigators will be asked survey questions about their first experience with the Amplatzer Trevisio Delivery System.	5years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Barathi Sethuraman, DVP Global Clinical Affairs Structural Heart

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): January 4, 2023
• Study Completion (Actual): January 4, 2023

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ABT-CIP_10319; Amplatzer Trevisio Intravascular Delivery System; Amplatzer Occluder devices
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Foramen Ovale, Patent; Heart Septal Defects, Atrial
• Other Study ID Numbers: ABT-CIP_10319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes