Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
251 participants
OBSERVATIONAL
2020-09-14
2025-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the 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.
Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder.
Interventions
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Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder.
Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder.
Eligibility Criteria
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Inclusion Criteria
2. Patient is of legal age and has provided his/her own written, informed consent.
OR
Patient is 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, have provided written informed consent on behalf of the minor according to local EC requirements
Exclusion Criteria
* 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
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Barathi Sethuraman
Role: STUDY_DIRECTOR
DVP Global Clinical Affairs Structural Heart
Locations
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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
Deutsches Herzzentrum München des Freistaates Bayern
München, , Germany
Fondazione Toscana Gabriele Monasterio Via Aurelia Sud
Massa, Tuscany, Italy
Azienda Ospedaliera Monaldi
Napoli, , Italy
Policlinico San Donato
San Donato Milanese, , Italy
Amsterdam Academic Medical Centre (AMC)
Amsterdam, , Netherlands
Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca ul.
Katowice, Silesian Voivodeship, Poland
Uniwersytekie Centrum Kliniczne
Gdansk, , Poland
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, , Poland
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario de la Paz - Pediatrico
Madrid, , Spain
Hospital Universitario de la Paz
Madrid, , Spain
Stadtspital Triemli
Zurich, , Switzerland
Countries
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Other Identifiers
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ABT-CIP_10319
Identifier Type: -
Identifier Source: org_study_id
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