AMPLATZER™ LAA Occluder Post Approval Study (PAS)

Completed

• Conditions: Atrial Fibrillation; Thromboembolism; Stroke
• Interventions: Device: AMPLATZER™ LAA Occluder

• Registration Number: NCT02964208
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-16
• Study Start: 2016-12-08
• Primary Completion: 2022-06-13
• Study Completion: 2022-08-10
• Results First Submitted: 2023-08-18
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-27
• Last Update Submitted: 2024-03-27
• Results First Posted: 2024-03-29
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LAA Occluder PAS	AMPLATZER™ LAA Occluder	Subjects who were treated with AMPLATZER LAA Occluders will be included.

Primary Outcome Measures

Name	Time	Method
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	Implant through 7 days	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
Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism	Implant through 24 months	The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death	Implant through 24 months	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

Secondary Outcome Measures

Name	Time	Method
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	Implant through 24 months	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.

Trial Locations

Locations (22)

Instituto Cardiovascular de Rosario; 🇦🇷 Rosario, Santa Fe, Argentina

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

The Royal Victoria Hospital; 🇨🇦 Montréal, Quebec, Canada

CHUM; 🇨🇦 Montreal, Quebec, Canada

Azienda Ospedaliera Monaldi; 🇮🇹 Napoli, Campania, Italy

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Castile And Leon, Spain

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Thuringia, Germany

Ospedale San Giovanni Bosco; 🇮🇹 Torino, Piedmonte, Italy

Università degli Studi di Padova; 🇮🇹 Padova, Veneto, Italy

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Clinic I Provincial de Barcelona; 🇪🇸 Barcelona, Catalonia, Spain

St. Marien-Hospital-Bonn; 🇩🇪 Bonn, North Rhine-Westphalia, Germany

Segeberger Kliniken GmbH; 🇩🇪 Bad Segeberg, Schleswig-Holstein, Germany

Hospital Clinico San Borja Arriarán; 🇨🇱 Santiago, Chile

Royal Columbian; 🇨🇦 New Westminster, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Hôpital Civil Marie Curie; 🇧🇪 Lodelinsart, Hainaut, Belgium

Cardioangiologisches Centrum am Bethanien Krankenhaus; 🇩🇪 Frankfurt, Hesse, Germany

Instituto Nacional del Torax; 🇨🇱 Providencia, Santiago, Chile

Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada