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Device
WATCHMAN FLX Pro Device for Atrial Fibrillation (SIMPLAAFY Trial)
N/A
Recruiting
Led By Saibal Kar, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after randomization
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare the safety and effectiveness of two different treatments with taking two medications together after receiving the WATCHMAN FLX Pro device in a real-world clinical setting. Summary: "This trial
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include complications from the device implantation like bleeding or heart-related issues, reactions to medications used during treatment, or other unforeseen risks associated with medical devices.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
746 Previous Clinical Trials
856,148 Total Patients Enrolled
78 Trials studying Atrial Fibrillation
32,640 Patients Enrolled for Atrial Fibrillation
Vivek Reddy, MDStudy ChairIcahn School of Medicine at Mount Sinai
35 Previous Clinical Trials
11,163 Total Patients Enrolled
19 Trials studying Atrial Fibrillation
5,709 Patients Enrolled for Atrial Fibrillation
Saibal Kar, MDPrincipal InvestigatorLos Robles Health System
6 Previous Clinical Trials
5,708 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
4,958 Patients Enrolled for Atrial Fibrillation
Walid Saliba, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
539 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
539 Patients Enrolled for Atrial Fibrillation