The WATCHMAN Implant is an alternative to blood thinners for people who need one. It’s a one-time procedure to reduce stroke risk from AFib for a lifetime. The WATCHMAN Implant is proven safe with over 20+ years of clinical and real-world experience and over 10+ clinical trials. Read more about the clinical evidence that supports its safety record.
There are risks associated with all medical procedures. Please talk with your doctor about the risks and benefits of the WATCHMAN Implant.
Clinical evidence for the WATCHMAN Implant
The WATCHMAN Implant has an unmatched record showing it’s a safe and effective option for lifelong stroke protection. The WATCHMAN Implant provides similar stroke risk protection as blood thinners – without the bleeding risks associated with the long-term use of blood thinners.1
Clinical data show the WATCHMAN Implant is safe
Over 10+ clinical trials and over 20+ years of clinical and real-world experience
The most implanted device for left atrial appendage closure
Over half a million people treated worldwide
Understanding the recent CHAMPION-AF clinical trial results
A clinical trial called CHAMPION-AF following 3,000 people just published results. The CHAMPION-AF trial is the largest randomized controlled trial comparing the WATCHMAN Implant with NOACs (a common type of blood thinner, such as Eliquis® or Xarelto®) as a first-line option to reduce stroke risk.
The CHAMPION-AF trial met all of its 3-year endpoints, which were: efficacy, bleeding rate excluding the procedure, bleeding rate overall, and net clinical benefit.
It’s important to know that the CHAMPION-AF trial investigated the WATCHMAN Implant as a first-line option. (“First-line option” means people got the WATCHMAN Implant first to treat stroke risk instead of taking blood thinners for a time.) That’s different than the current eligibility requirements of the WATCHMAN Implant, which requires a person to be taking a blood thinner and have an appropriate reason to seek an alternative treatment.
If you’re taking blood thinners and need an alternative, talk to your doctor to learn whether the WATCHMAN Implant might be right for you.
The OPTION trial: the WATCHMAN Implant is an alternative to blood thinners after an ablation
Did you know it’s possible to get an ablation and WATCHMAN Implant at the same time? A recent clinical trial called OPTION showed that for people who had both procedures at the same time, getting an ablation and WATCHMAN Implant was just as safe as getting ablation alone.2 And after an ablation, the WATCHMAN Implant was shown to be just as safe as blood thinners and just as effective at reducing stroke risk. Plus, people with the WATCHMAN Implant were 50% less likely to have a bleeding event.3
Find out if you’re a candidate for the WATCHMAN Implant. Take the quiz
WATCHMAN Implant vs. blood thinners in the PINNACLE FLX trial
A clinical trial called PINNACLE FLX showed that the WATCHMAN Implant procedure is safe and effective. The WATCHMAN Implant procedure had a high implant success rate of 99%* and a low major complication rate of 0.5%.**4
In the trial, 96% of people stopped their blood thinners 45 days after getting the WATCHMAN Implant.4 That’s because the WATCHMAN Implant closes the LAA in the heart – where most stroke-causing clots form – to eliminate the need for lifelong blood thinners.
Is the WATCHMAN Implant an alternative to blood thinners like Eliquis®?
Many people take blood thinners like Eliquis® and Xarelto® to reduce their stroke risk from AFib. Blood thinners are an effective way to reduce stroke risk, because they work by preventing stroke-causing clots from forming. But they can come with side effects and other challenges.
In multiple clinical studies, the WATCHMAN Implant has been shown to be a safe, proven alternative to blood thinners for people who need one.
Ready to leave blood thinners behind? Talk to your doctor to find out if the WATCHMAN Implant might be right for you.
Already took the quiz? Return to your personalized experience.
WATCHMAN FLX is an FDA approved device being studied for an expanded indication as a first line therapy vs NOAC for NVAF patients. The use of WATCHMAN or WATCHMAN FLX as a first-line therapy for stroke risk reduction in NVAF patients is considered investigational.
Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale.
*Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA.
**In a post-FDA approval analysis. Major complication is defined as an occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention.
References:
- Price MJ, Reddy VY, Valderrábano M, et al. Bleeding outcomes after left atrial appendage closure compared with long-term warfarin. JACC Cardiovasc Interv. 2015;8(15):1925-1932.
- Saliba W, Nair D, Swarup V, et al. Comparison of Left Atrial Appendage Closure and Oral Anticoagulation after Catheter Ablation for Atrial Fibrillation: Concomitant and Sequential Cohorts of the OPTION Randomized Controlled Trial. Heart Rhythm. 2025.
- Wazni M, Saliba W, Nair D, et al. Left Atrial Appendage Closure after Ablation for Atrial Fibrillation. N Engl J Med. 2025;392:1277-1287.
- Kar S., Doshi S., Sadhu A., et al. Primary Outcome Evaluation of the Next Generation LAAC Device: Results from the PINNACLE FLX Trial. Circulation. 2021;143:1754–1762.
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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.
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 puncture of the heart causing fluid to collect around the heart possibly leading towards the need for an additional procedure, allergic reaction, anesthesia risks, altered mental status or confusion after procedure, arrhythmias (irregular heartbeats), bleeding or throat pain from the TEE (Trans Esophageal Echo) probe, chest pain/discomfort, congestive heart failure, renal failure, excessive bleeding, gastrointestinal bleeding, groin puncture bleed, bruising at the catheter insertion site, groin pain, anemia (reduced red blood cells requiring transfusion), hypotension, infection/pneumonia (example: in or around your heart or lungs), misplacement of the device, improper seal of the appendage or movement of device from appendage wall, clot formation on the device, blood clot or air bubbles in the lungs or other organs, stroke, transient ischemic attack (temporary stroke-like symptoms), cranial bleed (bleeding in or around your brain), thrombosis (blockage of a blood vessel or vein by a clot) and 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. SH-2109508-AA