Trevisio Post-Approval Study

Active, not recruiting

• Conditions: VSD - Muscular Ventricular Septal Defect; PFO - Patent Foramen Ovale; PIVSD - Post Infarct Muscular Ventricular Septal Defect; ASD - Atrial Septal Defect
• Interventions: Device: Amplatzer™ Trevisio™ Intravascular Delivery System using 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

• Registration Number: NCT04433520
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Study Start: 2020-09-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-09
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASD/PFO cohort	Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder	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.
VSD cohort	Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder	Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.

Primary Outcome Measures

Name	Time	Method
Effectiveness Endpoint: Technical Success -successful deployment and release of at least one device	5years
Safety Endpoint : Device- or procedure-related serious adverse events through discharge or 7 days, whichever occurs first	5years	Includes: * 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

Trial Locations

Locations (22)

CHU Trousseau; 🇫🇷 Chambray-lès-Tours, France

CHU Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Centre Médico Chirurgical Marie Lannelongue; 🇫🇷 Le Plessis-Robinson, France

CHRU Lille; 🇫🇷 Lille, France

Hopital d'adulte de la Timone; 🇫🇷 Marseille, France

CHU Hopital G. & R. Laënnec; 🇫🇷 Nantes, France

Hopital Haut Leveque; 🇫🇷 Pessac, France

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel; 🇩🇪 Kiel, Germany

Deutsches Herzzentrum München des Freistaates Bayern; 🇩🇪 München, Germany

Fondazione Toscana Gabriele Monasterio Via Aurelia Sud; 🇮🇹 Massa, Tuscany, Italy

Azienda Ospedaliera Monaldi; 🇮🇹 Napoli, Italy

Policlinico San Donato; 🇮🇹 San Donato Milanese, Italy

Amsterdam Academic Medical Centre (AMC); 🇳🇱 Amsterdam, Netherlands

Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca ul.; 🇵🇱 Katowice, Silesia, Poland

Uniwersytekie Centrum Kliniczne; 🇵🇱 Gdańsk, Poland

The Cardinal Stefan Wyszynski Institute of Cardiology; 🇵🇱 Warsaw, Poland

Hospital Universitario Reina Sofia; 🇪🇸 Córdoba, Spain

Hospital Universitario de la Paz - Pediatrico; 🇪🇸 Madrid, Spain

Hospital Universitario de la Paz; 🇪🇸 Madrid, Spain

Stadtspital Triemli; 🇨🇭 Zürich, Switzerland