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Trevisio Post-Approval Study (Trevisio PAS)

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ClinicalTrials.gov Identifier: NCT04433520
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date June 12, 2020
First Posted Date June 16, 2020
Last Update Posted Date October 12, 2021
Actual Study Start Date September 14, 2020
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2020)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 12, 2020)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Trevisio Post-Approval Study
Official Title Amplatzer™ Trevisio™ Delivery System Post-Approval Study
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • PFO - Patent Foramen Ovale
  • ASD - Atrial Septum Defect
  • VSD - Muscular Ventricular Septal Defect
  • PIVSD - Post Infarct Muscular Ventricular Septal Defect
Intervention Device: Amplatzer™ Trevisio™ Intravascular Delivery System
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, Amplatzer ASO, Amplatzer Cribriform Occluder, Amplatzer Muscular VSD Occluder, and Amplatzer Post-Infarct Muscular VSD Occluder.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 12, 2020)
259
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 28, 2025
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Bart Janssens 0032 471 72 32 01 bart.janssens@abbott.com
Contact: Karine Miquel 0032 479 600 107 karine.miquel@abbott.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04433520
Other Study ID Numbers ABT-CIP_10319
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators Not Provided
PRS Account Abbott Medical Devices
Verification Date October 2021