SIMPLAAFY Clinical Trial

NCT06521463 | Active Not Recruiting DMC FDA Device

• 1 other identifier: S2508
• Study Type: interventional
• Target: 1,857
• Locations: 1 country
• Sites: 87

Brief Summary

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.

Conditions

Atrial Fibrillation; Stroke; Bleeding

Outcome Measures

Primary Outcomes (2)

• 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

  Non Inferiority

  6 months after randomization

• 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.

  Non Inferiority

  6 months after randomization

Study Arms (3)

Aspirin

EXPERIMENTAL

Aspirin 81-100 mg, daily post implant for duration of the clinical trial

Device: WATCHMAN FLX Pro LAAC Device

Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)

EXPERIMENTAL

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

Device: WATCHMAN FLX Pro LAAC Device

DAPT

ACTIVE COMPARATOR

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

Device: WATCHMAN FLX Pro LAAC Device

Interventions

WATCHMAN FLX Pro LAAC Device DEVICE

WATCHMAN FLX Pro LAAC Device Implantation

Also known as: WATCHMAN FLX Pro Left Atrial Appendage Closure Device

Aspirin; DAPT; Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is of legal age to participate in the study per the laws of their respective geography.
• Subject is an acceptable candidate for a WATCHMAN FLX Pro device per the approved Instructions for Use.
• Subject is deemed to be suitable for all protocol defined drug regimens in the control and both test arms.
• The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
• The subject is able and willing to return for required follow-up visits and examinations.

You may not qualify if:

• Subject's device implant procedure was aborted (i.e., failed implant).
• Subject has a device margin residual leak \> 0mm at time of implant.
• Occurrence of complications (major bleeding, systemic embolism, stroke, pericardial effusion requiring intervention) during the implant procedure, post-procedure, or prior to randomization.
• Subject has a contraindication to one of the three protocol defined drug regimens.
• Subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy.
• Subject has known history of severe liver disease including cirrhosis with a Child-Pugh classification C or D.
• Subject with known hypercoagulability disorder, mechanical heart valve, rheumatic heart disease, or recurrent deep vein thrombosis.
• Subject has intracardiac thrombus, LAA sludge, or dense spontaneous echo contrast (SEC) observed during pre-implant imaging.
• Subject has Modified Rankin Score of ≥ 3 at baseline.
• Subject has left ventricular ejection fraction (LVEF) \< 30%.
• Subject with known amyloid cardiomyopathy.
• Platelet count ≤ 100,000 x 109/L.
• Subject has an estimated glomerular filtration rate (eGFR) \< 30 ml/min (chronic kidney disease stage IV or V) or is on dialysis.
• Subject has a stroke (of any cause, whether ischemic or hemorrhagic) within 30 days prior to implant or prior to randomization.
• Subject has a documented myocardial infarction (MI) as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to implant or prior to randomization.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (87)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

HonorHealth Heart Group - Shea

Scottsdale, Arizona, 85258, United States

Location

Tucson Medical Center Healthcare

Tucson, Arizona, 85712, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Mills Peninsula Health Services

Burlingame, California, 94010, United States

Location

John Muir Medical Center

Concord, California, 94520, United States

Location

Scripps Memorial Hospital

La Jolla, California, 92037, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

St. John's Health Center

Los Angeles, California, 90404, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States

Location

Cardiology Associates Medical Group

Ventura, California, 93003, United States

Location

Colorado Heart and Vascular PC

Lakewood, Colorado, 80401, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Washington Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

HCA Florida Mercy Hospital

Miami, Florida, 33133, United States

Location

Naples Community Hospital

Naples, Florida, 34102, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Georgia Arrhythmia Consultants

Macon, Georgia, 31201, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31405, United States

Location

Straub Medical Center

Honolulu, Hawaii, 96813, United States

Location

St. Luke's Boise Medical Center

Boise, Idaho, 83712, United States

Location

Kootenai Medical Center

Coeur d'Alene, Idaho, 83814, United States

Location

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Community Heart and Vascular Hospita

Indianapolis, Indiana, 46250, United States

Location

Mercy Hospital Medical Center

Des Moines, Iowa, 50266, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Norton Hospital

Louisville, Kentucky, 40202, United States

Location

Charlton Memorial

Fall River, Massachusetts, 02720, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Corewell Health

Grand Rapids, Michigan, 49503, United States

Location

M Health Fairview St John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Mayo Clinic Foundation

Rochester, Minnesota, 55902, United States

Location

Centracare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

St. Luke's Hospital

St Louis, Missouri, 63141, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cooper Hospital - University Medical Center

Camden, New Jersey, 08103, United States

Location

Virtua Health

Marlton, New Jersey, 08053, United States

Location

Valley Hospital

Paramus, New Jersey, 07652, United States

Location

Lovelace Medical Center

Albuquerque, New Mexico, 87102, United States

Location

Northwell Health

Bay Shore, New York, 11706, United States

Location

Kaleida Health

Buffalo, New York, 14203, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Wake Medical Center

Raleigh, North Carolina, 27610, United States

Location

Bethesda North Hospital-Hospital

Cincinnati, Ohio, 45242, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Legacy Emanuel Hospital & Health Center

Portland, Oregon, 97227, United States

Location

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, 17101, United States

Location

Trident Medical Center

Charleston, South Carolina, 29406, United States

Location

Prisma Health

Columbia, South Carolina, 29203, United States

Location

MUSC Health Columbia Medical Center Downtown

Columbia, South Carolina, 29204, United States

Location

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

St. Thomas Heart

Nashville, Tennessee, 37203, United States

Location

Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States

Location

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States

Location

Orion Medical

Houston, Texas, 77034, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

Christus Trinity Mother Frances Health System-Hospital

Tyler, Texas, 75702, United States

Location

St. Mark's Hospital

Salt Lake City, Utah, 84124, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Chippenham & Johnston-Willis Hospital

Richmond, Virginia, 23235, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Monongalia General Hospital

Morgantown, West Virginia, 26505, United States

Location

Bellin Health

Green Bay, Wisconsin, 54305, United States

Location

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

• Saibal Kar, MD

  Los Robles Health System

  PRINCIPAL INVESTIGATOR

• Walid Saliba, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (87)