Atrial FibrillationNCT05997446
Amulet™ ADVANCE LAA
An observational study of Atrial Fibrillation and Stroke, run by Abbott Medical Devices at 16 sites in United States.
Trial summary
This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke, Bleeding
- What is being tested?
- Left atrial appendage occlusion (LAAO)
- Type of treatment
- Medical device
- How many people
- 610 participants
- Where
- 16 sitesUnited States
- Study dates
- 12 Jul 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with non-valvular atrial fibrillation who are at increased risk for ischemic stroke or systemic embolism.
Who may be able to join
- Intended for LAAO with the Amulet device
- At least 18 years of age
- Willing and capable of providing informed consent and participating in all testing associated with this clinical study
Who cannot join
- Presence of other conditions that, in the investigator's opinion, could limit the subject's ability to participate in follow-up
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Trident Medical Center
Charleston, South Carolina, 29406
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, 76104
Baptist Medical Center
Jacksonville, Florida, 32207
Bryan Heart
Lincoln, Nebraska, 68506
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Pinnacle Health System
Mechanicsburg, Pennsylvania, 17150
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, 37232
New York University Hospital
New York, New York, 10016
PERC - O'Fallon
O'Fallon, Illinois, 62269
CHI Health Creighton University Medical Center-Bergan Mercy
Omaha, Nebraska, 68124
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, 66211
Arizona Arrhythmia Research
Phoenix, Arizona, 85016
Heart Rhythm Associates
Shenandoah, Texas, 77380
Providence Hospital
Southfield, Michigan, 48075
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
Usman R. Siddiqui, MD
Winter Park, Florida, 32792
About this study
Official title: A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder
This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.
Read the detailed description
The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving the commercially available Amulet device in the United States. The Amulet device is intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation (NVAF) and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Being tested
- Left atrial appendage occlusion (LAAO)
- Medical subject headings
- Atrial Fibrillation, Stroke, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial appendage occlusion (LAAO)Device
Implantation of an Amplatzer Amulet left atrial appendage occluder
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint: Death or complications
Composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure related complications requiring an invasive surgical or percutaneous intervention within 7 days of implant or hospital discharge, whichever is later
Measured: Within 7 days of implant or hospital discharge, whichever is later
Device closure, defined as residual jet around the device ≤ 3mm
Device closure (defined as residual jet around the device ≤ 3mm) at the first follow-up visit documented by trans-esophageal echocardiography (TEE), as assessed by an independent core laboratory
Measured: Assessed at first trans-esophageal echocardiogram (TEE) occurring between 30-240 days post-implant.
Composite endpoint: Ischemic stroke or systemic embolism
Composite of ischemic stroke or systemic embolism through 24 months
Measured: 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 posted18 Aug 2023
- Study start12 Jul 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, Kansas City Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997446
- Sponsor's protocol ID
- ABT-CIP-10467
- Other IDs
- CRD_1056
- Status last verified
- Sep 2025
- First submitted
- 18 Jul 2023
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lakkireddy D, Saw J, Makkar A, Shah D, Satpathy R, Saric M, Sharma R, Cuoco F, Percell R, Manoukian G, Gage R, Anderson JA, Agarwal H. Outcomes of Amulet occluder implantation following Watchman screen failure in the ADVANCE LAA study: a real-world analysis of procedural success and safety. Europace. 2026 Sep 2;28(9):euag228. doi: 10.1093/europace/euag228.
PubMed 42644716
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder
- ClinicalTrials.gov ID
- NCT05997446
- Acronym / sponsor ID
- ABT-CIP-10467
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.
Detailed description
The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving the commercially available Amulet device in the United States. The Amulet device is intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation (NVAF) and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-valvular atrial fibrillation who are at increased risk for ischemic stroke or systemic embolism.
Key inclusion criteria (3 listed)
- Intended for LAAO with the Amulet device
- At least 18 years of age
- Willing and capable of providing informed consent and participating in all testing associated with this clinical study
Key exclusion criteria (1 listed)
- Presence of other conditions that, in the investigator's opinion, could limit the subject's ability to participate in follow-up
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 |
|---|---|---|
| Left atrial appendage occlusion (LAAO)Implantation of an Amplatzer Amulet left atrial appendage occluder | Device | – |
Primary outcome
Composite endpoint: Death or complications
Time frame: Within 7 days of implant or hospital discharge, whichever is later
Composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure related complications requiring an invasive surgical or percutaneous intervention within 7 days of implant or hospital discharge, whichever is later
Device closure, defined as residual jet around the device ≤ 3mm
Time frame: Assessed at first trans-esophageal echocardiogram (TEE) occurring between 30-240 days post-implant.
Device closure (defined as residual jet around the device ≤ 3mm) at the first follow-up visit documented by trans-esophageal echocardiography (TEE), as assessed by an independent core laboratory
Composite endpoint: Ischemic stroke or systemic embolism
Time frame: Through 24 months
Composite of ischemic stroke or systemic embolism through 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 42644716Lakkireddy D, Saw J, Makkar A, Shah D, Satpathy R, Saric M, Sharma R, Cuoco F, Percell R, Manoukian G, Gage R, Anderson JA, Agarwal H. Outcomes of Amulet occluder implantation following Watchman screen failure in the ADVANCE LAA study: a real-world analysis of procedural success and safety. Europace. 2026 Sep 2;28(9):euag228. doi: 10.1093/europace/euag228.
- 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.
Dhanunjaya Lakkireddy, MD principal investigator
Kansas City Cardiac Arrhythmia Research Foundation
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Abbott Medical Devices at 16 sites in United States.
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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Composite endpoint: Death or complications (time frame: Within 7 days of implant or hospital discharge, whichever is later). 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?
On the ClinicalTrials.gov record for NCT05997446, which also lists 1 linked publication.
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 1 Oct 2025.