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Atrial Fibrillation (AF)NCT07287436

Elite AF IDE Trial (Elite AF)

A study testing WATCHMAN Elite LAAC Device in people with Atrial Fibrillation (AF) and Stroke, run by Boston Scientific Corporation at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for anticoagulation therapy to reduce the risk of stroke. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation (AF), Stroke
What is being tested?
WATCHMAN Elite LAAC Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
2 sitesUnited States
Study dates
18 Sep 2026to Nov 2032
Phase
Interventional
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

Who may be able to join

  • The subject is of legal age to participate in the study per the laws of their respective geography.
  • The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
  • The subject has an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.
  • The subject is deemed to be suitable for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy following WATCHMAN Elite Device implant.
  • The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
  • The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
  • The subject is able and willing to return for required follow-up visits and examinations.

Who cannot join

  • The subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment upon study physician's discretion).
  • The subject has a documented life expectancy of less than 2 years.
  • The subject is currently enrolled, or plans to enroll, in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed.
  • The subject has a known contraindication to percutaneous catheterization procedure or is contraindicated for transesophageal echocardiography (TEE) or cardiac computed tomography (CT).
  • The subject has documented left ventricular ejection fraction (LVEF) < 30%.
  • The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment.
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  • The subject has a LAA anatomy that is incompatible with the device selection requirements outlined in the Instructions for Use (IFU).
  • The subject has a known hypercoagulability disorder, mechanical heart valve in any position, known amyloid cardiomyopathy, or recurrent deep vein thrombosis (DVT).
  • The subject has known history of complex atheroma with mobile plaque of the descending aorta and/or aortic arch.
  • The subject has estimated glomerular filtration rate (eGFR) <30 ml/min (chronic kidney disease stage IV or V) or is on dialysis.
  • The subject has a cardiac tumor.
  • The subject has signs/symptoms of acute or chronic pericarditis.
  • The subject has an active infection.
  • The subject has documented surgical closure of the left atrial appendage.
  • The subject has a history of atrial septal repair or has an ASD/PFO device.
  • The subject had a prior procedure with any commercial LAAC device that was either aborted or unsuccessful.
  • The subject is contraindicated to oral short-term anticoagulation post-implant.
  • The subject is contraindicated to Aspirin and P2Y12 inhibitor.
  • The subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy.
  • The subject has an active bleed, or the subject has a major bleeding event per ISTH definitions within the 90 days prior to enrollment. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source are a further exclusion regardless of timing of the bleeding event.
  • The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.
  • The subject has a documented myocardial infarction (MI) as either a non-ST elevation MI (NSTEMI) or an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to enrollment.
  • The subject had or is planning to have any cardiac or non-cardiac invasive or surgical procedure within 30 days prior to or 60 days after the WATCHMAN Elite Device implant (including, but not limited to: cardioversion, percutaneous coronary intervention (PCI), cataract surgery, endoscopy, etc.)
  • The subject had cardiac ablation within the 60 days prior to or plans to have a cardiac ablation within 60 days after the WATCHMAN Elite implant
  • Platelet count ≤ 100,000/μL
  • Pre-procedure Imaging Anatomical Exclusion Criteria:
  • The subject has a LAA anatomy that is incompatible with the device selection requirements outlined in the Instructions for Use (IFU).
  • The subject has an existing pericardial effusion with a circumferential echo-free space > 5mm, a significant mitral valve stenosis (i.e., MV area <1.5 cm2), and/or there is evidence (clinically or echocardiographically) of tamponade physiology.
  • The subject has intracardiac thrombus, LAA sludge (gelatinous, non-adherent, intracavitary echo-density more layered than dense spontaneous echo contrast (SEC) seen continuously throughout cardiac cycle) or dense SEC visualized by TEE prior to device implant.
  • The subject has a high-risk patent foramen ovale (PFO) with an atrial septal aneurysm excursion > 15mm or length > 15mm.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Patricia Keating contact

1-800-CARDIAC

patricia.keating@bsci.com

United States2 sites, 2 recruiting

  • Sanger Heart and Vascular Institute / Atrium Health

    Charlotte, North Carolina, 28204

    Houston Chapman, 704-355-4692, Houston.Chapman@advocatehealth.org

    Michael Rinaldi, MD

    Recruiting

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401

    Cody Poindexter, 870-336-8181, cpoindexter@dnairresearch.com

    Devi Nair, MD

    Recruiting

Other trials in United States

About this study

Official title: Investigational Device Evaluation of the WATCHMAN Elite™ Left Atrial Appendage Closure Technology

The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for anticoagulation therapy to reduce the risk of stroke.

Read the detailed description

This study is a prospective, non-randomized, multicenter investigation to establish the safety and effectiveness of the WATCHMAN Elite LAAC Device for subjects with non-valvular atrial fibrillation who are suitable for anticoagulation therapy to reduce the risk of stroke but who have a rationale to seek a non-pharmacologic alternative.

Being tested
WATCHMAN Elite LAAC Device
Medical subject headings
Atrial Fibrillation, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WATCHMAN Elite LAAC DeviceDevice

    WATCHMAN Elite LAAC Device Implantation

Study groups in NCT07287436
Study groupRoleWhat they receive
Non Rollin CohortExperimentalSubjects will receive the WATCHMAN Elite LAAC Device and the population used for the study's endpoint analyses.
Receives: Device: WATCHMAN Elite LAAC Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary effectiveness endpoint is the rate of effective LAA closure.

    The rate of effective LAA closure defined as peri-device flow ≤ 5mm as demonstrated by TEE at the 45-day visit

    Measured: 45 days

  2. The primary safety endpoint is the occurrence of pre-specified events between the time of implant and 7 days following the procedure or by hospital discharge, whichever is later.

    Occurrence of one of the following events between the time of implant and 7 days following the procedure or by hospital discharge, whichever is later

    • All-cause death
    • Ischemic stroke
    • Systemic embolism
    • Device or procedure related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.

    Note: Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and minor nonsurgical treatments of access site complications are excluded from this endpoint

    Measured: By hospital discharge or 7 days post-procedure (whichever is later)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start18 Sep 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionNov 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
A total of 400 non rollin subjects will be enrolled at investigational centers in the United States. Additionally roll-in subjects will be enrolled.
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07287436
Sponsor's protocol ID
S2566
Status last verified
Oct 2026
First submitted
12 Dec 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing WATCHMAN Elite LAAC Device in people with Atrial Fibrillation (AF) and Stroke, run by Boston Scientific Corporation at 2 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 7 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Contact Patricia Keating (1-800-CARDIAC, patricia.keating@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary effectiveness endpoint is the rate of effective LAA closure. (time frame: 45 days). The study lists 2 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 NCT07287436.

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 16 Oct 2026.

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