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.
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
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.
United States2 sites, 2 recruiting
- 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
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.
- Conditions
- Atrial Fibrillation (AF), Stroke
- 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 group | Role | What they receive |
|---|---|---|
| Non Rollin Cohort | Experimental | Subjects 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.
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
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.
- First posted17 Dec 2025
- Study start18 Sep 2026
- Primary completionJan 2028 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- 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)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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