AMPLATZER™ LAA Occluder Post Approval Study (PAS)

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02964208
Collaborator
(none)
1,000
22
78.7
45.5
0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: AMPLATZER™ LAA Occluder

Detailed Description

The AMPLATZER LAA Occluder device will be clinically evaluated through this post approval study. This is a non-randomized multicenter study on patients who have undergone a procedure to implant an AMPLATZER LAA Occluder or will undergo an implant of an AMPLATZER LAA Occluder.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
AMPLATZER™ LAA Occluder Post Approval Study (PAS)
Actual Study Start Date :
Dec 9, 2016
Actual Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Jun 30, 2023

Outcome Measures

Primary Outcome Measures

  1. The occurrence of one or more adverse events listed in description below [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

  2. The occurrence of ischemic stroke or systemic embolism as listed in description below. [Implant through 24 months]

    The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment

  3. The occurrence of a major adverse event within 7 days [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

Secondary Outcome Measures

  1. Comparison of the observed rate of ischemic stroke at 24months with the CHA2DS2-VASc predicted rate [Implant through 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Cardiovascular de Rosario Rosario Santa Fe Argentina 2000
2 Hôpital Civil Marie Curie Lodelinsart Hainaut Belgium 6042
3 Royal Columbian New Westminster British Columbia Canada V3L 3W5
4 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
5 St. Paul's Hospital Vancouver British Columbia Canada V6Z 2E8
6 Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7
7 St. Michael's Hospital Toronto Ontario Canada M5B 1W8
8 Montreal Heart Institute Montreal Quebec Canada H2L 4M1
9 CHUM Montreal Quebec Canada H2X 3E4
10 The Royal Victoria Hospital Montréal Quebec Canada H4A 3J1
11 Instituto Nacional del Torax Providencia Santiago Chile
12 Hospital Clinico San Borja Arriarán Santiago Chile 8320000
13 Cardioangiologisches Centrum am Bethanien Krankenhaus Frankfurt Hesse Germany 60389
14 St. Marien-Hospital-Bonn Bonn North Rhine-Westphalia Germany 53115
15 Segeberger Kliniken GmbH Bad Segeberg Schleswig-Holstein Germany 23795
16 Zentralklinik Bad Berka GmbH Bad Berka Thuringia Germany 99438
17 Azienda Ospedaliera Monaldi Napoli Campania Italy 80131
18 Ospedale San Giovanni Bosco Torino Piedmonte Italy 10154
19 Università degli Studi di Padova Padova Veneto Italy 35128
20 Hospital Universitario de Salamanca Salamanca Castile And Leon Spain 37007
21 Hospital Clinic I Provincial de Barcelona Barcelona Catalonia Spain 8028
22 Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain 28222

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Study Director: Maren Wagner, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT02964208
Other Study ID Numbers:
  • SJM-CIP-10122
First Posted:
Nov 16, 2016
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Abbott Medical Devices
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022