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New catheter system tested for safer heart defect repair

NCT ID NCT04433520

Completed Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new delivery system for implanting devices that close holes in the heart, such as PFO and ASD. It involved 254 patients and measured how well the system worked and how safe it was. The goal was to confirm that the system performs well in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Amplatzer Trevisio Intravascular Delivery System (a catheter-based device used to implant heart defect occluders)
What this could lead to
If successful, this delivery system could make it easier and safer for doctors to implant devices that close holes in the heart, reducing the need for open-heart surgery.
What could go wrong
This is a post-approval study, meaning the device is already on the market. The results confirm real-world safety and effectiveness but do not represent a breakthrough. Risks include serious complications like heart perforation or device clotting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

atrial septal defect atrial septal defect, ostium secundum type patent foramen ovale ventricular septal defect

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ASD - ATRIAL SEPTAL DEFECT PFO - PATENT FORAMEN OVALE PIVSD - POST INFARCT MUSCULAR VENTRICULAR SEPTAL DEFECT VSD - MUSCULAR VENTRICULAR SEPTAL DEFECT

Contacts and locations

Locations

  • Amsterdam Academic Medical Centre (AMC)

    Amsterdam, 1105 AZ, Netherlands

  • Azienda Ospedaliera Monaldi

    Naples, 80131, Italy

  • CHRU Lille

    Lille, 59037, France

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • CHU Hopital G. & R. Laënnec

    Nantes, 44093, France

  • CHU Trousseau

    Chambray-lès-Tours, 37170, France

  • Centre Médico Chirurgical Marie Lannelongue

    Le Plessis-Robinson, 92350, France

  • Deutsches Herzzentrum Berlin

    Berlin, 13353, Germany

  • Deutsches Herzzentrum München des Freistaates Bayern

    München, 80636, Germany

  • Fondazione Toscana Gabriele Monasterio Via Aurelia Sud

    Massa, Tuscany, 54100, Italy

  • Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca ul.

    Katowice, Silesian Voivodeship, 40-635, Poland

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545, Germany

  • Hopital Haut Leveque

    Pessac, 33604, France

  • Hopital d'adulte de la Timone

    Marseille, 13005, France

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario de la Paz

    Madrid, 28046, Spain

  • Hospital Universitario de la Paz - Pediatrico

    Madrid, 28046, Spain

  • Policlinico San Donato

    San Donato Milanese, 20097, Italy

  • Stadtspital Triemli

    Zurich, 8063, Switzerland

  • The Cardinal Stefan Wyszynski Institute of Cardiology

    Warsaw, 04-628, Poland

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105, Germany

  • Uniwersytekie Centrum Kliniczne

    Gdansk, 80-952, Poland

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