Clinical trial NCT04433520: Trevisio Post-Approval Study
Official title: Amplatzer™Trevisio™Delivery System Post-Approval Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 251
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Effectiveness Endpoint: Technical Success -successful deployment and release of at least one device
timeFrame: 5years
measure: Safety Endpoint : Device- or procedure-related serious adverse events through discharge or 7 days, whichever occurs first
timeFrame: 5years
Secondary outcomes:
Other outcomes:
measure: Descriptive Endpoints
timeFrame: 5years
Locations:
city: Chambray-lès-Tours
country: France
facility: CHU Trousseau
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Le Plessis-Robinson
country: France
facility: Centre Médico Chirurgical Marie Lannelongue
city: Lille
country: France
facility: CHRU Lille
city: Marseille
country: France
facility: Hopital d'adulte de la Timone
city: Nantes
country: France
facility: CHU Hopital G. & R. Laënnec
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: München
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
city: Massa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio Via Aurelia Sud
state: Tuscany
city: Napoli
country: Italy
facility: Azienda Ospedaliera Monaldi
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
city: Amsterdam
country: Netherlands
facility: Amsterdam Academic Medical Centre (AMC)
city: Katowice
country: Poland
facility: Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca ul.
state: Silesia
city: Gdańsk
country: Poland
facility: Uniwersytekie Centrum Kliniczne
city: Warsaw
country: Poland
facility: The Cardinal Stefan Wyszynski Institute of Cardiology
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario de la Paz - Pediatrico
city: Madrid
country: Spain
facility: Hospital Universitario de la Paz
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: DVP Global Clinical Affairs Structural Heart
name: Barathi Sethuraman
role: STUDY_DIRECTOR
References: