SIMPLAAFY Clinical Trial

In this clinical trial, a doctor will implant the FDA-approved WATCHMAN FLX™ Pro device. Then the doctor will prescribe either a single drug or several drugs to support the healing process.

Typically, after a WATCHMAN procedure, doctors prescribe a combination of antiplatelets, aspirin or blood thinners. In this trial, the doctor will prescribe either a single dose or a lower dose of these drugs. The trial will evaluate which option can help to reduce stroke and bleeding risk.

If you decide to participate, you will be randomized into either the test or control group. Randomization means that you are put into a group by chance. 

Patients assigned to the test group will receive one of the lower dose medications: 

EITHER aspirin only for the entire 12 months of the study

Patients assigned to the control group will receive a full dose of medication:

Dual antiplatelet therapy for 6 months. This therapy includes aspirin and clopidogrel, also known as Plavix™. Then patients will take aspirin only for 6 months. 

Women and people of color are less likely to be part of a clinical trial.^1,2 This trial welcomes all eligible patients regardless of race, ethnicity or gender.

• Less than 7% of clinical trial participants are Black^1,2
• Less than 6% of clinical trials participants are Hispanic^1,2
• Women represent 33% of clinical trial participants^1,2

Why is diversity in clinical trials important?

• Clinical trial results should apply to everyone. To do this, trials need non-white and non-male volunteers.
• Diseases, such as diabetes and heart disease, affect racial or ethnic groups and women differently.
• How different groups respond to treatment might not become known until after a device or drug is approved and in use.
• Treatments should be developed based on how everyone is affected. If not, minority and female patients may miss out on potentially lifesaving screenings and treatments. 
  

In this trial, three drug regimens are being compared. All are intended to stop blood clots from forming on the surface of the WATCHMAN Implant. Each volunteer will receive one of the following drug regimens: 

• Some participants will be prescribed aspirin for 12 months
• Some will be prescribed a lower dose of blood thinners for 3 months, and then aspirin for 9 months. Blood thinners are also known as NOACs. 
  
• Some will be prescribed dual antiplatelet therapy. This therapy includes aspirin and clopidogrel, also known as Plavix™, for 6 months. Then patients will take aspirin only for 6 months 
  

You will also visit your doctor for required screenings and follow-up visits. The visits will take place at 45 days, 3 months, 6 months and 12 months. 

* “AFib” and “atrial fibrillation” refer to atrial fibrillation not caused by a heart valve problem.

References

1. Clark L, Watkins L, Pina IL, et al. Increasing diversity in clinical trials: overcoming critical barriers. Curr Probl Cariol. 2019;44:148–172. 
2. Zhang T, Tsang W, Wijeysundera HC, Ko DT. Reporting and representation of ethnic minorities in cardiovascular trials: a systemic review. Am Heart J. 2013;166:52–57.

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Content on this web page is for Informational Purposes only and does not constitute medical advice and should not be used for medical diagnoses. Boston Scientific strongly recommends that you consult with your physician on all matters pertaining to your health or to address any clinical/medical questions.

WATCHMAN™ Left Atrial Appendage Closure Implant

Important Safety Information

The WATCHMAN FLX and WATCHMAN FLX Pro Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke.

With all medical procedures there are risks associated with the implant procedure and the use of the device. The risks include but are not limited to accidental heart puncture, air embolism, allergic reaction, anemia, anesthesia risks, arrhythmias, AV (Arteriovenous) fistula, bleeding or throat pain from the TEE (Trans Esophageal Echo) probe, blood clot or air bubbles in the lungs or other organs, bruising at the catheter insertion site, clot formation on the device, cranial bleed, excessive bleeding, gastrointestinal bleeding, groin puncture bleed, hypotension, infection/pneumonia, pneumothorax, pulmonary edema, pulmonary vein obstruction, renal failure, stroke, thrombosis and transient ischemic attack. In rare cases death can occur.

Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the device.