WATCHMAN FLX Pro Device for Atrial Fibrillation
(SIMPLAAFY Trial)
Recruiting in Palo Alto (17 mi)
+34 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Scientific Corporation
Must not be taking: Anticoagulants, P2Y12 inhibitors
Disqualifiers: Severe liver disease, Hypercoagulability, Stroke, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
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.
Eligibility Criteria
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
Key
I am a suitable candidate for the WATCHMAN FLX Pro device as per its usage guidelines.
I can understand and am willing to sign the consent form.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to one of three therapy arms: Aspirin only, Reduced dose NOAC, or DAPT, and remain on treatment for 12 months
12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)Experimental Treatment1 Intervention
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
Group II: AspirinExperimental Treatment1 Intervention
Aspirin 81-100 mg, daily post implant for duration of the clinical trial
Group III: DAPTActive Control1 Intervention
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:
🇺🇸 Approved in United States as WATCHMAN FLX Pro for:
- Reduction of stroke risk in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tucson Medical Center HealthcareTucson, AZ
Los Robles Hospital & Medical CenterThousand Oaks, CA
Grandview Medical CenterBirmingham, AL
Colorado Heart and Vascular PCLakewood, CO
More Trial Locations
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Who Is Running the Clinical Trial?
Boston Scientific CorporationLead Sponsor