PFO - Patent Foramen OvaleTrevisioPASNCT04433520
Trevisio Post-Approval Study
An observational study of PFO - Patent Foramen Ovale and ASD - Atrial Septal Defect, run by Abbott Medical Devices at 22 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect
- What is being tested?
- Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder and Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
- Type of treatment
- Medical device
- How many people
- 254 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 14 Sep 2020to 4 Jan 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
- 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
- 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
Who cannot join
- 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.
- 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
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- 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
- 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
- Body weight <8 kg
- Tetralogy of Fallot
- Intracardiac thrombi on echocardiography
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
France7 sites
CHU Trousseau
Chambray-lès-Tours, 37170
CHU Gabriel Montpied
Clermont-Ferrand, 63003
Centre Médico Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
CHRU Lille
Lille, 59037
Hopital d'adulte de la Timone
Marseille, 13005
CHU Hopital G. & R. Laënnec
Nantes, 44093
Hopital Haut Leveque
Pessac, 33604
Germany4 sites
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Deutsches Herzzentrum Berlin
Berlin, 13353
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105
Deutsches Herzzentrum München des Freistaates Bayern
München, 80636
Italy3 sites
Fondazione Toscana Gabriele Monasterio Via Aurelia Sud
Massa, Tuscany, 54100
Azienda Ospedaliera Monaldi
Naples, 80131
Policlinico San Donato
San Donato Milanese, 20097
Poland3 sites
Uniwersytekie Centrum Kliniczne
Gdansk, 80-952
Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca ul.
Katowice, Silesian Voivodeship, 40-635
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, 04-628
Spain3 sites
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Universitario de la Paz - Pediatrico
Madrid, 28046
Hospital Universitario de la Paz
Madrid, 28046
Netherlands1 site
Amsterdam Academic Medical Centre (AMC)
Amsterdam, 1105 AZ
About this study
Official title: Amplatzer™Trevisio™Delivery System Post-Approval Study
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
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
- Being tested
- Amplatzer™ Trevisio™ Intravascular Delivery System using 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
- Keywords
- ABT-CIP_10319, Amplatzer Trevisio Intravascular Delivery System, Amplatzer Occluder devices
- Medical subject headings
- Foramen Ovale, Patent, Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform OccluderDevice
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 OccluderDevice
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness Endpoint: Rate of Technical Success
The Technical success, defined as successful deployment and release of at least one device
Measured: 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
Measured: through discharge or 7 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start14 Sep 2020
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PFO - Patent Foramen OvaleStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barathi Sethuraman, Study director, DVP Global Clinical Affairs Structural Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433520
- Sponsor's protocol ID
- ABT-CIP_10319
- Acronym
- TrevisioPAS
- Status last verified
- Feb 2026
- First submitted
- 12 Jun 2020
- Last updated
- 16 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplatzer™Trevisio™Delivery System Post-Approval Study
- ClinicalTrials.gov ID
- NCT04433520
- Acronym / sponsor ID
- TrevisioPAS / ABT-CIP_10319
- Conditions
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
- Keywords
- ABT-CIP_10319, Amplatzer Trevisio Intravascular Delivery System, Amplatzer Occluder devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Posted 16 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD/PFO cohort | – | Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform OccluderSubjects 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. |
| VSD cohort | – | Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD OccluderSubjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
- 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
- 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
Key exclusion criteria (17 listed)
- 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.
- Exclusion Criteria for Patients Undergoing ASD Closure with the Amplatzer ASO or Amplatzer ASD-MF Occluder
- Exclusion Criteria for Patients Undergoing PFO Closure
- Body weight <8 kg
- Tetralogy of Fallot
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform OccluderAmplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder. | Device | ASD/PFO cohort |
| Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD OccluderAmplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder. | Device | VSD cohort |
Primary outcome
Effectiveness Endpoint: Rate of Technical Success
Time frame: at pre-hospital discharge or 7 days after the procedure
The Technical success, defined as successful deployment and release of at least one device
Safety Endpoint : Device- or Procedure-related Serious Adverse Events.
Time frame: through discharge or 7 days after the procedure
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barathi Sethuraman study director
DVP Global Clinical Affairs Structural Heart
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PFO - Patent Foramen Ovale and ASD - Atrial Septal Defect, run by Abbott Medical Devices at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Germany, Italy, Poland, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness Endpoint: Rate of Technical Success (time frame: at pre-hospital discharge or 7 days after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.