Trevisio Post-Approval Study

NCT04433520 | Completed Results FDA Device

• 1 other identifier: ABT-CIP_10319
• Study Type: observational
• Target: 254
• Locations: 7 countries
• Sites: 22

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.

Conditions

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

Keywords

ABT-CIP_10319; Amplatzer Trevisio Intravascular Delivery System; Amplatzer Occluder devices

Outcome Measures

Primary Outcomes (2)

• Effectiveness Endpoint: Rate of Technical Success

  The Technical success, defined as successful deployment and release of at least one device

  at pre-hospital discharge or 7 days after the procedure

• Safety Endpoint : Device- or Procedure-related Serious Adverse Events.

  The primary safety endpoint is device- or procedure-related serious adverse events through discharge or 7 days, whichever is earlier, including: * 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

  through discharge or 7 days after the procedure

Study Arms (2)

ASD/PFO cohort

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.

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

VSD cohort

Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.

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

Interventions

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

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

ASD/PFO cohort

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

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

VSD cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical study will enroll male and female adults and children with a PFO (adults only), ASD or VSD who are indicated for transcatheter closure. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any study-specific procedures not considered standard of care.

You may qualify if:

• Patient was indicated for implantation with the Amplatzer Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure) OR subject was indicated for implantation with the Amplatzer PFO Occluder
• Patient was of legal age and has provided his/her own written, informed consent
• Patient was a minor and has provided verbal and/or written informed consent or assent per local EC requirements, and his/her legally authorized representative, or representatives, had provided written informed consent on behalf of the minor according to local EC requirements
• Patient was indicated for implantation with the Amplatzer Muscular VSD Occluder OR patient was indicated for implantation with the Amplatzer Post-Infarct Muscular VSD Occluder

You may not qualify if:

• Presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Principal Investigator's opinion, could limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.
• Patients known to have extensive congenital cardiac anomaly that can only be adequately repaired by cardiac surgery
• Patients known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement
• Patients known to have demonstrated intracardiac thrombus on echocardiography (especially left atrial or left atrial appendage thrombi)
• Patients whose size or condition (e.g., too small for transesophageal echocardiography \[TEE\] probe, catheter size, vasculature size, active infection) would cause the patient to be a poor candidate for cardiac catheterization
• Patients with defect margins less than 5 mm to the coronary sinus, inferior vena cava rim, an atrioventricular valve, or the right upper lobe pulmonary vein
• Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained. Thrombus must be ruled out prior to introducing the delivery system.
• Active endocarditis or other infections producing bacteremia
• Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size
• Anatomy in which the Amplatzer™ PFO device size required would interfere with other intra-cardiac or intravascular structures, such as valves or pulmonary veins
• Patients with known hypercoagulable states
• Patients with intra-cardiac mass or vegetation, thrombus, or tumor
• Body weight \<8 kg
• Tetralogy of Fallot
• Intracardiac thrombi on echocardiography

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (22)

CHU Trousseau

Chambray-lès-Tours, 37170, France

Location

CHU Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Centre Médico Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

CHRU Lille

Lille, 59037, France

Location

Hopital d'adulte de la Timone

Marseille, 13005, France

Location

CHU Hopital G. & R. Laënnec

Nantes, 44093, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Deutsches Herzzentrum München des Freistaates Bayern

München, 80636, Germany

Location

Fondazione Toscana Gabriele Monasterio Via Aurelia Sud

Massa, Tuscany, 54100, Italy

Location

Azienda Ospedaliera Monaldi

Naples, 80131, Italy

Location

Policlinico San Donato

San Donato Milanese, 20097, Italy

Location

Amsterdam Academic Medical Centre (AMC)

Amsterdam, 1105 AZ, Netherlands

Location

Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca ul.

Katowice, Silesian Voivodeship, 40-635, Poland

Location

Uniwersytekie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

The Cardinal Stefan Wyszynski Institute of Cardiology

Warsaw, 04-628, Poland

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario de la Paz - Pediatrico

Madrid, 28046, Spain

Location

Hospital Universitario de la Paz

Madrid, 28046, Spain

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

MeSH Terms

Conditions

Foramen Ovale, Patent; Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Karine Miquel, PhD
• Organization: Abbott

karine.miquel@abbott.com

+32 479 600 107

Study Officials

• Barathi Sethuraman

  DVP Global Clinical Affairs Structural Heart

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: September 14, 2020
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: March 16, 2026
• Results First Posted: March 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3); ES (3); CH (1); FR (7); DE (4); NL (1); IT (3)