AMPLATZER™ LAA Occluder Post Approval Study (PAS)

Stroke Clinical Trial

Official title:

AMPLATZER™ LAA Occluder Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964208
• Other study ID #: SJM-CIP-10122
• Status: Completed
• Start date: December 8, 2016
• Est. completion date: August 10, 2022

Study information

• Verified date: March 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this multicenter, non-randomized observational post-approval is to compile real world outcome data on the use of an AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF). The AMPLATZER LAA Occluders is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: August 10, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Documented history of nonvalvular atrial fibrillation

• Subjects in whom an AMPLATZER LAA Occluder device is intended to be implanted or Subjects who underwent an AMPLATZER LAA Occluder implant attempt after the device was approved in the applicable geography

Exclusion Criteria:

• Women of childbearing potential who are, or plan to become, pregnant during the time of the study

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke
• Thromboembolism

Intervention

Device:
• AMPLATZER™ LAA Occluder
The AMPLATZER™ LAA Occluder is intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular Atrial Fibrillation (AF). It may be considered for use in patients who have a high risk of stroke and bleeding and are deemed by their physician to have an appropriate rationale to seek a non-pharmacologic alternative to long term anticoagulants.

Locations

Country	Name	City	State
Argentina	Instituto Cardiovascular de Rosario	Rosario	Santa Fe
Belgium	Hôpital Civil Marie Curie	Lodelinsart	Hainaut
Canada	CHUM	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	The Royal Victoria Hospital	Montréal	Quebec
Canada	Royal Columbian	New Westminster	British Columbia
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Chile	Instituto Nacional del Torax	Providencia	Santiago
Chile	Hospital Clinico San Borja Arriarán	Santiago
Germany	Zentralklinik Bad Berka GmbH	Bad Berka	Thuringia
Germany	Segeberger Kliniken GmbH	Bad Segeberg	Schleswig-Holstein
Germany	St. Marien-Hospital-Bonn	Bonn	North Rhine-Westphalia
Germany	Cardioangiologisches Centrum am Bethanien Krankenhaus	Frankfurt	Hesse
Italy	Azienda Ospedaliera Monaldi	Napoli	Campania
Italy	Università degli Studi di Padova	Padova	Veneto
Italy	Ospedale San Giovanni Bosco	Torino	Piedmonte
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona	Catalonia
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario de Salamanca	Salamanca	Castile And Leon

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Argentina,  Belgium,  Canada,  Chile,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death	The occurrence of one or more the composite of stroke (including ischemic or hemorrhagic), systemic embolism, or cardiovascular or unexplained death at 24 months from the time of enrollment	Implant through 24 months
Primary	Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism	The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment	Implant through 24 months
Primary	Primary Safety Endpoint: Number of Subjects With All Cause Death, Ischemic Stroke, Systemic Embolism, or Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Repair	The occurrence of one of the following events between the time of implant and within 7 days of the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular repair	Implant through 7 days
Secondary	Comparison of the Relative Risk Decrease Of Observed Rate of Ischemic Stroke at 24 Months With the CHA2DS2-VASc Predicted Rate for the Implant Population	The secondary endpoint comparing the observed rate of ischemic stroke at 24 months with the congestive heart failure, hypertension, age = 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category (CHA2DS2-VASc) score predicted rate for the implant population. The following calculation was used to calculate the Relative Risk Decrease: (Predicted Rate minus Observed Rate) divided by Predicted Rate = Relative Risk Decrease.	Implant through 24 months