WATCHMAN FLX Pro Device for Atrial Fibrillation
(SIMPLAAFY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of different medication regimens for individuals with atrial fibrillation who have had the WATCHMAN FLX Pro device (a left atrial appendage closure device) implanted. It compares three approaches: a combination of aspirin and clopidogrel, a reduced dose of a blood thinner (NOAC), and aspirin alone. The goal is to determine which treatment plan best prevents complications after device implantation. This trial suits those with atrial fibrillation considering the WATCHMAN FLX Pro device implantation. As an unphased trial, it provides an opportunity to explore various treatment options and contribute to a broader understanding of post-implant care.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications. However, you cannot participate if you require long-term anticoagulation therapy for reasons other than reducing stroke risk from atrial fibrillation or if you need chronic P2Y12 inhibitor therapy.
What prior data suggests that the WATCHMAN FLX Pro device is safe for atrial fibrillation?
Research shows that the WATCHMAN FLX Pro device is safe for patients with atrial fibrillation. Studies have found that serious problems are rare, with only 0.45% of patients experiencing major issues within the first week after the procedure. Another study reported a 0.37% rate of major issues within a week or before leaving the hospital. These findings suggest that most patients tolerate the device well.
For those considering joining a trial, it's important to know that this device is already approved to help reduce stroke risk in people with certain heart conditions. This approval indicates it has been tested and found safe for use in people, at least for its current purpose.12345Why are researchers excited about this trial?
Researchers are excited about the WATCHMAN FLX Pro Device for atrial fibrillation because it offers a unique alternative to traditional blood thinners. Unlike standard drugs like warfarin or other anticoagulants, this device is implanted in the heart to physically block clots from forming, potentially reducing bleeding risks associated with long-term medication use. It provides a targeted solution that could improve patient safety and life quality by minimizing the side effects typically seen with oral anticoagulants. This innovative approach could be a game-changer for those who cannot tolerate conventional therapies.
What evidence suggests that the WATCHMAN FLX Pro device is effective for atrial fibrillation?
Research shows that the WATCHMAN FLX Pro device is a good option for people with atrial fibrillation to lower their risk of stroke. Studies have found a very low chance of major problems soon after the procedure. Specifically, one study found that only 0.45% of patients experienced significant issues within a week. The device has been successfully implanted in all procedures, and some patients can even go home the same day. This trial will compare the WATCHMAN FLX Pro device with different medication regimens. The WATCHMAN FLX Pro is as effective as blood thinners in preventing strokes but offers greater safety, allowing many patients to stop using these medications. This makes it a promising choice for those needing an alternative to long-term blood thinner use.24567
Who Is on the Research Team?
Walid Saliba, MD
Principal Investigator
The Cleveland Clinic
Saibal Kar, MD
Principal Investigator
Los Robles Health System
Vivek Reddy, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
The SIMPLAAFY trial is for adults who can have the WATCHMAN FLX Pro device implanted according to its usage instructions. Participants must be able to take all study drugs and come back for follow-ups. They need to understand and agree in writing to join the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to one of three therapy arms: Aspirin only, Reduced dose NOAC, or DAPT, and remain on treatment for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- WATCHMAN FLX Pro LAAC Device
Trial Overview
This trial tests if using one drug alone is as safe and effective as taking two together after getting a WATCHMAN FLX Pro device, which helps prevent strokes in people with atrial fibrillation by closing off an area of the heart.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
Reduced 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
Aspirin 81-100 mg, daily post implant for duration of the clinical trial
DAPT (aspirin 81-100 mg + clopidogrel 75 mg), for the first 6-months daily followed by aspirin only for the duration of the clinical trial
WATCHMAN FLX Pro LAAC Device is already approved in United States for the following indications:
- Reduction of stroke risk in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology
Citations
SURPASS One-Year Results - Study Design
The SURPASS one-year outcomes analysis reported a 0.45% major procedural adverse event rate within seven days or at hospital discharge.
Evaluating the New Watchman FLX Pro 40 mm Device
Results: The study demonstrated a 100% procedural success rate, with all patients undergoing same-day discharge. No procedural or periprocedural ...
OPTION Clinical Trial - Design, Outcomes - WATCHMAN FLX
The primary endpoints showed WATCHMAN FLX™ was equally effective to anticoagulation, with a superior safety profile, which allowed patients to eliminate ...
4.
bostonscientific.com
bostonscientific.com/en-EU/products/laac-system/watchman-flx/clinical-evidence.htmlClinical Evidence
This data reinforces the outstanding safety of WATCHMAN FLX with 0.37% major procedural adverse event rate within 7 days or hospital discharge and 98% ...
WATCHMAN FLX™ Pro
INDICATIONS FOR USE. The WATCHMAN FLX Pro Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular ...
Clinical Evidence - Studies and Trials - WATCHMAN FLX
The OPTION clinical trial is the first randomized, head-to-head study comparing left atrial appendage closure (LAAC) to oral anticoagulants (OACs)—95% of ...
SURPASS real-world data
These data continue to support the best-in-class safety profile of the WATCHMAN FLX Implant with a 0.45% major procedural adverse event rate within seven days ...
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