New catheter system tested for safer heart defect repair
NCT ID NCT04433520
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.
Disclaimer
Read more
Show less
This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for PFO - PATENT FORAMEN OVALE are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
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