Trevisio Post-Approval Study

PFO - Patent Foramen Ovale Clinical Trial

— TrevisioPAS  

Official title:

Amplatzer™Trevisio™Delivery System Post-Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04433520
• Other study ID #: ABT-CIP_10319
• Status: Recruiting
• Start date: September 14, 2020
• Est. completion date: October 15, 2025

Study information

• Verified date: March 2024
• Source: Abbott Medical Devices
• Contact: Laetitia Beullens
• Phone: +32 277 46 937
• Email: laetitia.beullens[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. NOTE: The enrollment for the VSD cohort is still recruiting (3 subjects at this moment); therefore, the overall status of the study is Recruiting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 251
• Est. completion date: October 15, 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Heart Septal Defects
• Heart Septal Defects, Atrial
• Heart Septal Defects, Ventricular
• PFO - Patent Foramen Ovale
• PIVSD - Post Infarct Muscular Ventricular Septal Defect
• VSD - Muscular Ventricular Septal Defect

Intervention

Device:
• Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder
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 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.

Locations

Country	Name	City	State
France	CHU Trousseau	Chambray-lès-Tours
France	CHU Gabriel Montpied	Clermont-Ferrand
France	Centre Médico Chirurgical Marie Lannelongue	Le Plessis-Robinson
France	CHRU Lille	Lille
France	Hopital d'adulte de la Timone	Marseille
France	CHU Hopital G. & R. Laënnec	Nantes
France	Hopital Haut Leveque	Pessac
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen	Georgstraße 11
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel
Germany	Deutsches Herzzentrum München des Freistaates Bayern	München	Lazarettstraße 36
Italy	Fondazione Toscana Gabriele Monasterio Via Aurelia Sud	Massa	Tuscany
Italy	Azienda Ospedaliera Monaldi	Napoli
Italy	Policlinico San Donato	San Donato Milanese
Netherlands	Amsterdam Academic Medical Centre (AMC)	Amsterdam
Poland	Uniwersytekie Centrum Kliniczne	Gdansk
Poland	Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca ul.	Katowice	Silesia
Poland	The Cardinal Stefan Wyszynski Institute of Cardiology	Warsaw
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Hospital Universitario de la Paz	Madrid
Spain	Hospital Universitario de la Paz - Pediatrico	Madrid
Switzerland	Stadtspital Triemli	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Descriptive Endpoints	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.	5years
Primary	Effectiveness Endpoint: Technical Success -successful deployment and release of at least one device		5years
Primary	Safety Endpoint : Device- or procedure-related serious adverse events through discharge or 7 days, whichever occurs first	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	5years