Atrial FibrillationNCT02964208
AMPLATZER™ LAA Occluder Post Approval Study (PAS)
An observational study of Atrial Fibrillation and Thromboembolism, run by Abbott Medical Devices at 22 sites in 7 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Thromboembolism, Stroke
- What is being tested?
- AMPLATZER™ LAA Occluder
- Type of treatment
- Medical device
- How many people
- 520 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 8 Dec 2016to 10 Aug 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject population will include participants that are > 18 years old and diagnosed with NVAF.
Who may be able to join
- 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
Who cannot join
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
Canada8 sites
Montreal Heart Institute
Montreal, Quebec, H2L 4M1
CHUM
Montreal, Quebec, H2X 3E4
The Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
Royal Columbian
New Westminster, British Columbia, V3L 3W5
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
St. Paul's Hospital
Vancouver, British Columbia, V6Z 2E8
Germany4 sites
Zentralklinik Bad Berka GmbH
Bad Berka, Thuringia, 99438
Segeberger Kliniken GmbH
Bad Segeberg, Schleswig-Holstein, 23795
St. Marien-Hospital-Bonn
Bonn, North Rhine-Westphalia, 53115
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse, 60389
Italy3 sites
Azienda Ospedaliera Monaldi
Naples, Campania, 80131
Università degli Studi di Padova
Padova, Veneto, 35128
Ospedale San Giovanni Bosco
Torino, Piedmonte, 10154
Spain3 sites
Hospital Clinic I Provincial de Barcelona
Barcelona, Catalonia, 8028
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007
Chile2 sites
Instituto Nacional del Torax
Providencia, Santiago Metropolitan
Hospital Clinico San Borja Arriarán
Santiago, 8320000
Argentina1 site
Instituto Cardiovascular de Rosario
Rosario, Santa Fe Province, 2000
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation, Thromboembolism, Stroke
- Being tested
- AMPLATZER™ LAA Occluder
- Keywords
- Atrial Fibrillation, Stroke, Left Atrial Appendage, Cardiac Plug, Amulet, Thromboembolism
- Medical subject headings
- Atrial Fibrillation, Thromboembolism, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPLATZER™ LAA OccluderDevice
Also called AMPLATZER™ Cardiac Plug™, AMPLATZER™ Amulet™
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.
| Study group | Role | What they receive |
|---|---|---|
| LAA Occluder PAS | Subjects who were treated with AMPLATZER LAA Occluders will be included. Receives: Device: AMPLATZER™ LAA Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Implant through 24 months
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
Measured: 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
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
Measured: Implant through 7 days
Secondary outcomes (1)
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.
Measured: Implant through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start8 Dec 2016
- Primary completion13 Jun 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Palmer, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964208
- Sponsor's protocol ID
- SJM-CIP-10122
- Status last verified
- Mar 2024
- First submitted
- 6 Oct 2016
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMPLATZER™ LAA Occluder Post Approval Study
- ClinicalTrials.gov ID
- NCT02964208
- Acronym / sponsor ID
- SJM-CIP-10122
- Conditions
- Atrial Fibrillation, Thromboembolism, Stroke
- Keywords
- Atrial Fibrillation, Stroke, Left Atrial Appendage, Cardiac Plug, Amulet, Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Posted 29 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAA Occluder PAS | – | Device: AMPLATZER™ LAA OccluderSubjects who were treated with AMPLATZER LAA Occluders will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population will include participants that are > 18 years old and diagnosed with NVAF.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMPLATZER™ LAA OccluderAlso: AMPLATZER™ Cardiac Plug™, AMPLATZER™ Amulet™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. | Device | LAA Occluder PAS |
Primary outcome
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
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
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Palmer study director
Abbott
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Thromboembolism, run by Abbott Medical Devices at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Canada, Germany, Italy, Spain, Chile and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.