Trevisio Post-Approval Study (Trevisio PAS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04433520 |
Recruitment Status :
Recruiting
First Posted : June 16, 2020
Last Update Posted : March 22, 2022
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Condition or disease | Intervention/treatment |
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PFO - Patent Foramen Ovale ASD - Atrial Septum Defect VSD - Muscular Ventricular Septal Defect PIVSD - Post Infarct Muscular Ventricular Septal Defect | Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, Amplatzer ASO or Amplatzer Cribriform Occluder Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder |
Study Type : | Observational |
Estimated Enrollment : | 254 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Amplatzer™ Trevisio™ Delivery System Post-Approval Study |
Actual Study Start Date : | September 14, 2020 |
Estimated Primary Completion Date : | September 2025 |
Estimated Study Completion Date : | October 15, 2025 |

Group/Cohort | Intervention/treatment |
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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.
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Device: Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, Amplatzer ASO or Amplatzer Cribriform Occluder
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, Amplatzer ASO or Amplatzer Cribriform Occluder. |
VSD cohort
Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.
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Device: 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. |
- Technical Success -successful deployment and release of at least one device [ Time Frame: 5years ]
- Device- or procedure-related serious adverse events through discharge or 7 days, whichever occurs first [ Time Frame: 5years ]
Includes:
- 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
- Descriptive Endpoints [ Time Frame: 5years ]
- The number of times the device is recaptured
- The number of times the device is repositioned
- Total fluoroscopy time
- Ease of use - investigators will be asked survey questions about their first experience with the Amplatzer Trevisio Delivery System.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria
- Patient is 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 is indicated for implantation with the Amplatzer PFO Occluder OR subject is indicated for implantation with the Amplatzer Muscular VSD Occluder OR subject is indicated for implantation with the Amplatzer Post-Infarct Muscular VSD Occluder
- 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
- 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.
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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
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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
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Exclusion Criteria for Patients Undergoing VSD Closure with the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
- Body weight <8 kg
- Tetralogy of Fallot
- Intracardiac thrombi on echocardiography

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433520
Contact: Laetitia Beullens | +32 277 46 937 | laetitia.beullens@abbott.com | |
Contact: Karine Miquel | 0032 479 600 107 | karine.miquel@abbott.com |

Study Director: | Barathi Sethuraman | DVP Global Clinical Affairs Structural Heart |
Responsible Party: | Abbott Medical Devices |
ClinicalTrials.gov Identifier: | NCT04433520 |
Other Study ID Numbers: |
ABT-CIP_10319 |
First Posted: | June 16, 2020 Key Record Dates |
Last Update Posted: | March 22, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
ABT-CIP_10319 Amplatzer Trevisio Intravascular Delivery System Amplatzer Occluder devices |
Heart Septal Defects Foramen Ovale, Patent Heart Septal Defects, Ventricular Heart Septal Defects, Atrial Heart Defects, Congenital |
Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities |