CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 254 enrolled
Drug / intervention
Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04433520
NCT04433520N/ACompleted
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Amplatzer™Trevisio™Delivery System Post-Approval Study

Abbott Medical Devices·observational·Posted Jun 16, 2020·Updated Mar 16, 2026

In Brief

An observational study evaluating Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder and Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder for PFO - Patent Foramen Ovale and 3 related conditions. Completed, enrolled 254 participants across 22 sites in 7 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
CountriesFrance, Germany, Italy, Netherlands, Poland, Spain, Switzerland
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 16, 2020
Enrollment StartSep 14, 2020
Primary CompletionJan 4, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.0 years ago

Interventions

Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluderdevice

Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder.

Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluderdevice

Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder.