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Atrial FibrillationSIMPLAAFYNCT06521463

SIMPLAAFY Clinical Trial

A study testing WATCHMAN FLX Pro LAAC Device in people with Atrial Fibrillation and Stroke, run by Boston Scientific Corporation at 86 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting. 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?
WATCHMAN FLX Pro LAAC Device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,857 participants
Where
86 sitesUnited States
Study dates
1 Oct 2024to Jan 2027
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

  • Subject is of legal age to participate in the study per the laws of their respective geography.
  • Subject is an acceptable candidate for a WATCHMAN FLX Pro device per the approved Instructions for Use.
  • Subject is deemed to be suitable for all protocol defined drug regimens in the control and both test arms.
  • 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

  • Subject's device implant procedure was aborted (i.e., failed implant).
  • Subject has a device margin residual leak > 0mm at time of implant.
  • Occurrence of complications (major bleeding, systemic embolism, stroke, pericardial effusion requiring intervention) during the implant procedure, post-procedure, or prior to randomization.
  • Subject has a contraindication to one of the three protocol defined drug regimens.
  • Subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy.
  • Subject has known history of severe liver disease including cirrhosis with a Child-Pugh classification C or D.
Show all 26Show fewer
  • Subject with known hypercoagulability disorder, mechanical heart valve, rheumatic heart disease, or recurrent deep vein thrombosis.
  • Subject has intracardiac thrombus, LAA sludge, or dense spontaneous echo contrast (SEC) observed during pre-implant imaging.
  • Subject has Modified Rankin Score of ≥ 3 at baseline.
  • Subject has left ventricular ejection fraction (LVEF) < 30%.
  • Subject with known amyloid cardiomyopathy.
  • Platelet count ≤ 100,000 x 109/L.
  • Subject has an estimated glomerular filtration rate (eGFR) < 30 ml/min (chronic kidney disease stage IV or V) or is on dialysis.
  • Subject has a stroke (of any cause, whether ischemic or hemorrhagic) within 30 days prior to implant or prior to randomization.
  • Subject has a documented myocardial infarction (MI) as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to implant or prior to randomization.
  • Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 6-months after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.).
  • Subject has a major bleeding event per International Society on Thrombosis and Haemostasis (ISTH) definitions within the 30 days prior to implant or prior to randomization. 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.
  • Subject has an active bleed.
  • Subject has a cardiac tumor.
  • Subject has signs/symptoms of acute or chronic pericarditis.
  • Subject has an active infection.
  • There is evidence of tamponade physiology.
  • Subject has New York Heart Association Class IV congestive heart failure at the time of implant or prior to randomization.
  • Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
  • Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.
  • Subject has a documented life expectancy of less than 12 months.

Trial locations and contacts

86 sites in 1 country.

86 sites in 1 country

United States86 sites

  • Lovelace Medical Center

    Albuquerque, New Mexico, 87102

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Texas Cardiac Arrhythmia Research

    Austin, Texas, 78705

  • Northwell Health

    Bay Shore, New York, 11706

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • University of Alabama Birmingham

    Birmingham, Alabama, 35233

  • Grandview Medical Center

    Birmingham, Alabama, 35243

  • St. Luke's Boise Medical Center

    Boise, Idaho, 83712

  • Kaleida Health

    Buffalo, New York, 14203

  • Mills Peninsula Health Services

    Burlingame, California, 94010

  • Cooper Hospital - University Medical Center

    Camden, New Jersey, 08103

  • Trident Medical Center

    Charleston, South Carolina, 29406

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Bethesda North Hospital-Hospital

    Cincinnati, Ohio, 45242

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Prisma Health

    Columbia, South Carolina, 29203

  • MUSC Health Columbia Medical Center Downtown

    Columbia, South Carolina, 29204

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • John Muir Medical Center

    Concord, California, 94520

  • Mercy Hospital Medical Center

    Des Moines, Iowa, 50266

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Evanston Hospital

    Evanston, Illinois, 60201

  • Charlton Memorial

    Fall River, Massachusetts, 02720

  • Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138

  • Corewell Health

    Grand Rapids, Michigan, 49503

  • Bellin Health

    Green Bay, Wisconsin, 54305

  • Pinnacle Health at Harrisburg Hospital

    Harrisburg, Pennsylvania, 17101

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Straub Medical Center

    Honolulu, Hawaii, 96813

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas, 77024

  • Orion Medical

    Houston, Texas, 77034

  • Community Heart and Vascular Hospita

    Indianapolis, Indiana, 46250

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist Medical Center

    Jacksonville, Florida, 32207

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401

  • University of Kansas

    Kansas City, Kansas, 66160

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Scripps Memorial Hospital

    La Jolla, California, 92037

  • Colorado Heart and Vascular PC

    Lakewood, Colorado, 80401

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • St. John's Health Center

    Los Angeles, California, 90404

  • Norton Hospital

    Louisville, Kentucky, 40202

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Georgia Arrhythmia Consultants

    Macon, Georgia, 31201

  • M Health Fairview St John's Hospital

    Maplewood, Minnesota, 55109

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Virtua Health

    Marlton, New Jersey, 08053

  • Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, 53226

  • Monongalia General Hospital

    Morgantown, West Virginia, 26505

  • Midwest Cardiovascular Institute

    Naperville, Illinois, 60540

  • Naples Community Hospital

    Naples, Florida, 34102

  • St. Thomas Heart

    Nashville, Tennessee, 37203

  • New York University Medical Center

    New York, New York, 10016

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Valley Hospital

    Paramus, New Jersey, 07652

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018

  • Legacy Emanuel Hospital & Health Center

    Portland, Oregon, 97227

  • Rex Hospital

    Raleigh, North Carolina, 27607

  • Wake Medical Center

    Raleigh, North Carolina, 27610

  • Chippenham & Johnston-Willis Hospital

    Richmond, Virginia, 23235

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014

  • Mayo Clinic Foundation

    Rochester, Minnesota, 55902

  • Centracare Heart and Vascular Center

    Saint Cloud, Minnesota, 56303

  • St. Mark's Hospital

    Salt Lake City, Utah, 84124

  • Methodist Hospital

    San Antonio, Texas, 78229

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Memorial Health University Medical Center

    Savannah, Georgia, 31405

  • HonorHealth Heart Group - Shea

    Scottsdale, Arizona, 85258

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • St. Luke's Hospital

    St Louis, Missouri, 63141

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Los Robles Hospital & Medical Center

    Thousand Oaks, California, 91360

  • PIMA Heart and Vascular

    Tucson, Arizona, 85712

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Christus Trinity Mother Frances Health System-Hospital

    Tyler, Texas, 75702

  • Cardiology Associates Medical Group

    Ventura, California, 93003

  • Washington Hospital

    Washington D.C., District of Columbia, 20010

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy

The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.

Read the detailed description

This study is a prospective, randomized, open-label, triple-arm, multi-center trial. Subjects will be randomized 1:1:1 to one of the three therapy arms and remain on treatment through the end of study (12 months):

  1. Aspirin only
  2. Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)
  3. DAPT
Being tested
WATCHMAN FLX Pro LAAC Device
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.

  • WATCHMAN FLX Pro LAAC DeviceDevice

    Also called WATCHMAN FLX Pro Left Atrial Appendage Closure Device

    WATCHMAN FLX Pro LAAC Device Implantation

Study groups in NCT06521463
Study groupRoleWhat they receive
AspirinExperimentalAspirin 81-100 mg, daily post implant for duration of the clinical trial
Receives: Device: WATCHMAN FLX Pro LAAC Device
Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)ExperimentalReduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) for the first 3 months daily, post implant, followed by aspirin only for the duration of the clinical trial
Receives: Device: WATCHMAN FLX Pro LAAC Device
DAPTActive comparatorDAPT (aspirin 81-100 mg + clopidogrel 75 mg), for the first 6-months daily followed by aspirin only for the duration of the clinical trial
Receives: Device: WATCHMAN FLX Pro LAAC Device

What is being measured

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

  1. Reduced dose NOAC Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the reduced dose NOAC arm tested for non-inferiority compared to the DAPT arm

    Non Inferiority

    Measured: 6 months after randomization

  2. Aspirin Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the Aspirin arm tested for non-inferiority compared to the DAPT arm.

    Non Inferiority

    Measured: 6 months after randomization

Timeline

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

  1. First posted26 Jul 2024
  2. Study start1 Oct 2024
  3. Primary completion7 Jul 2026
  4. Study completionJan 2027 (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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,857 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06521463
Sponsor's protocol ID
S2508
Acronym
SIMPLAAFY
Status last verified
Oct 2026
First submitted
22 Jul 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing WATCHMAN FLX Pro LAAC Device in people with Atrial Fibrillation and Stroke, run by Boston Scientific Corporation at 86 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 5 inclusion and 26 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 13 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 86 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?

Reduced dose NOAC Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the reduced dose NOAC arm tested for non-inferiority compared to the DAPT arm (time frame: 6 months after randomization). 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 NCT06521463.

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 13 Oct 2026.

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SIMPLAAFY Clinical Trial (NCT06521463) | AzTrials