NCT04433520

Trevisio Post-Approval Study

Amplatzer™Trevisio™Delivery System Post-Approval Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 254 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-09-14
• Primary completion: 2023-01-04
• Completion: 2023-01-04
• First posted: 2020-06-16
• Last updated: 2026-03-16
• Results posted: 2026-03-16

Locations

22 sites across 7 countries: France, Germany, Italy, Netherlands, Poland, Spain, Switzerland

Regulatory

• FDA-regulated device study