AMPLATZER™ LAA Occluder Post Approval Study (PAS)

March 27, 2024 updated by: Abbott Medical Devices

AMPLATZER™ LAA Occluder Post Approval Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Instituto Cardiovascular de Rosario
  • Belgium
    • Hainaut
      • Lodelinsart, Hainaut, Belgium, 6042
        • Hôpital Civil Marie Curie
  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W5
        • Royal Columbian
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V6Z 2E8
        • St. Paul's Hospital
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM
      • Montréal, Quebec, Canada, H4A 3J1
        • The Royal Victoria Hospital
  • Chile
      • Santiago, Chile, 8320000
        • Hospital Clinico San Borja Arriarán
    • Santiago
      • Providencia, Santiago, Chile
        • Instituto Nacional del Torax
  • Germany
    • Hesse
      • Frankfurt, Hesse, Germany, 60389
        • Cardioangiologisches Centrum am Bethanien Krankenhaus
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53115
        • St. Marien-Hospital-Bonn
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany, 23795
        • Segeberger Kliniken GmbH
    • Thuringia
      • Bad Berka, Thuringia, Germany, 99438
        • Zentralklinik Bad Berka GmbH
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Azienda Ospedaliera Monaldi
    • Piedmonte
      • Torino, Piedmonte, Italy, 10154
        • Ospedale San Giovanni Bosco
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Universita Degli Studi Di Padova
  • Spain
    • Castile And Leon
      • Salamanca, Castile And Leon, Spain, 37007
        • Hospital Universitario De Salamanca
    • Catalonia
      • Barcelona, Catalonia, Spain, 8028
        • Hospital Clinic i Provincial de Barcelona
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta De Hierro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The subject population will include participants that are > 18 years old and diagnosed with NVAF.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
LAA Occluder PAS
Subjects who were treated with AMPLATZER LAA Occluders will be included.
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.
Other Names:
  • AMPLATZER™ Cardiac Plug™
  • AMPLATZER™ Amulet™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death
Time Frame: 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
Implant through 24 months
Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism
Time Frame: Implant through 24 months
The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
Implant through 24 months
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
Time Frame: 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
Implant through 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Implant through 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ryan Palmer, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJM-CIP-10122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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