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New catheter system tested for safer heart defect repair

NCT ID NCT04433520

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Participants

254 people

The number who actually took part.

Started

Sep 2020

Finished

Jan 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. 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 2. Patient was of legal age and has provided his/her own written, informed consent OR 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 3. 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 Exclusion Criteria 1. 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. 2. Exclusion Criteria for Patients Undergoing ASD Closure with the Amplatzer ASO or Amplatzer ASD-MF Occluder * 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 3. Exclusion Criteria for Patients Undergoing PFO Closure * 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 4. Body weight \<8 kg 5. Tetralogy of Fallot 6. Intracardiac thrombi on echocardiography

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.