Trevisio Post-Approval Study (TrevisioPAS)

February 23, 2026 updated by: Abbott Medical Devices

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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
        • Hopital Haut Leveque
  • 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 Sofia
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at pre-hospital discharge or 7 days after the procedure
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
through discharge or 7 days after the procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Descriptive Endpoints
Time Frame: 5years
  • 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Barathi Sethuraman, DVP Global Clinical Affairs Structural Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PFO - Patent Foramen Ovale

Clinical Trials on Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings