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

• 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

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

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