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Trevisio Post-Approval Study

NCT04433520 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 254

Last updated 2026-03-16

Study results available
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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.

Conditions

  • PFO - Patent Foramen Ovale
  • ASD - Atrial Septal Defect
  • VSD - Muscular Ventricular Septal Defect
  • PIVSD - Post Infarct Muscular Ventricular Septal Defect

Interventions

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.

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Barathi Sethuraman · DVP Global Clinical Affairs Structural Heart

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2023-01-04
Completion
2023-01-04
FDA Device
Yes

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04433520 on ClinicalTrials.gov