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Trevisio Post-Approval Study (Trevisio PAS)

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
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief 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

Condition or disease Intervention/treatment
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

Detailed Description:
The Trevisio PAS study will evaluate the safety and effectiveness of the Amplatzer Trevisio Delivery System for facilitating percutaneous, transcatheter implantation of the following Amplatzer Occluder devices: Amplatzer PFO Occluder, Amplatzer Septal Occluder (ASO), Amplatzer Multi-Fenestrated Septal Occluder "Cribriform" (ASD-MF), Amplatzer Muscular VSD Occluder (MuscVSD), and Amplatzer Post-Infarct Muscular VSD Occluder (PIVSD). Trevisio PAS has two separate cohorts. The ASD/PFO cohort will comprise 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 VSD cohort will comprise subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.

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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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.
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.




Primary Outcome Measures :
  1. Technical Success -successful deployment and release of at least one device [ Time Frame: 5years ]
  2. 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


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria

  1. 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
  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

  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. 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

Information from the National Library of Medicine

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


Contacts
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Contact: Laetitia Beullens +32 277 46 937 laetitia.beullens@abbott.com
Contact: Karine Miquel 0032 479 600 107 karine.miquel@abbott.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Barathi Sethuraman DVP Global Clinical Affairs Structural Heart
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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

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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
Keywords provided by Abbott Medical Devices:
ABT-CIP_10319
Amplatzer Trevisio Intravascular Delivery System
Amplatzer Occluder devices
Additional relevant MeSH terms:
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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