ACTIVE_NOT_RECRUITING

SIMPLAAFY Clinical Trial

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Conditions

Atrial FibrillationStrokeBleeding

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy

Quick Facts

Study Start:2024-10-01
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06521463

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is of legal age to participate in the study per the laws of their respective geography.
  2. * Subject is an acceptable candidate for a WATCHMAN FLX Pro device per the approved Instructions for Use.
  3. * Subject is deemed to be suitable for all protocol defined drug regimens in the control and both test arms.
  4. * The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
  5. * The subject is able and willing to return for required follow-up visits and examinations.
  1. * Subject's device implant procedure was aborted (i.e., failed implant).
  2. * Subject has a device margin residual leak \> 0mm at time of implant.
  3. * Occurrence of complications (major bleeding, systemic embolism, stroke, pericardial effusion requiring intervention) during the implant procedure, post-procedure, or prior to randomization.
  4. * Subject has a contraindication to one of the three protocol defined drug regimens.
  5. * Subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy.
  6. * Subject has known history of severe liver disease including cirrhosis with a Child-Pugh classification C or D.
  7. * Subject with known hypercoagulability disorder, mechanical heart valve, rheumatic heart disease, or recurrent deep vein thrombosis.
  8. * Subject has intracardiac thrombus, LAA sludge, or dense spontaneous echo contrast (SEC) observed during pre-implant imaging.
  9. * Subject has Modified Rankin Score of ≥ 3 at baseline.
  10. * Subject has left ventricular ejection fraction (LVEF) \< 30%.
  11. * Subject with known amyloid cardiomyopathy.
  12. * Platelet count ≤ 100,000 x 109/L.
  13. * Subject has an estimated glomerular filtration rate (eGFR) \< 30 ml/min (chronic kidney disease stage IV or V) or is on dialysis.
  14. * Subject has a stroke (of any cause, whether ischemic or hemorrhagic) within 30 days prior to implant or prior to randomization.
  15. * 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.
  16. * Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 6-months after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.).
  17. * Subject has a major bleeding event per International Society on Thrombosis and Haemostasis (ISTH) definitions within the 30 days prior to implant or prior to randomization. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source are a further exclusion regardless of timing of the bleeding event.
  18. * Subject has an active bleed.
  19. * Subject has a cardiac tumor.
  20. * Subject has signs/symptoms of acute or chronic pericarditis.
  21. * Subject has an active infection.
  22. * There is evidence of tamponade physiology.
  23. * Subject has New York Heart Association Class IV congestive heart failure at the time of implant or prior to randomization.
  24. * Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
  25. * Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.
  26. * Subject has a documented life expectancy of less than 12 months.

Contacts and Locations

Principal Investigator

Vivek Reddy, MD
STUDY_CHAIR
Icahn School of Medicine at Mount Sinai
Saibal Kar, MD
PRINCIPAL_INVESTIGATOR
Los Robles Health System
Walid Saliba, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

University of Alabama Birmingham
Birmingham, Alabama, 35233
United States
Grandview Medical Center
Birmingham, Alabama, 35243
United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85018
United States
HonorHealth Heart Group - Shea
Scottsdale, Arizona, 85258
United States
Tucson Medical Center Healthcare
Tucson, Arizona, 85712
United States
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
United States
Mills Peninsula Health Services
Burlingame, California, 94010
United States
John Muir Medical Center
Concord, California, 94520
United States
Scripps Memorial Hospital
La Jolla, California, 92037
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
St. John's Health Center
Los Angeles, California, 90404
United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
United States
Cardiology Associates Medical Group
Ventura, California, 93003
United States
Colorado Heart and Vascular PC
Lakewood, Colorado, 80401
United States
Medical Center of the Rockies
Loveland, Colorado, 80538
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Washington Hospital
Washington D.C., District of Columbia, 20010
United States
Baptist Medical Center
Jacksonville, Florida, 32207
United States
HCA Florida Mercy Hospital
Miami, Florida, 33133
United States
Naples Community Hospital
Naples, Florida, 34102
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Georgia Arrhythmia Consultants
Macon, Georgia, 31201
United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30060
United States
Memorial Health University Medical Center
Savannah, Georgia, 31405
United States
Straub Medical Center
Honolulu, Hawaii, 96813
United States
St. Luke's Boise Medical Center
Boise, Idaho, 83712
United States
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814
United States
Evanston Hospital
Evanston, Illinois, 60201
United States
Midwest Cardiovascular Institute
Naperville, Illinois, 60540
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
United States
Community Heart and Vascular Hospita
Indianapolis, Indiana, 46250
United States
Mercy Hospital Medical Center
Des Moines, Iowa, 50266
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
University of Kansas
Kansas City, Kansas, 66160
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Norton Hospital
Louisville, Kentucky, 40202
United States
Charlton Memorial
Fall River, Massachusetts, 02720
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Corewell Health
Grand Rapids, Michigan, 49503
United States
M Health Fairview St John's Hospital
Maplewood, Minnesota, 55109
United States
Mayo Clinic Foundation
Rochester, Minnesota, 55902
United States
Centracare Heart and Vascular Center
Saint Cloud, Minnesota, 56303
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801
United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
St. Luke's Hospital
St Louis, Missouri, 63141
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Cooper Hospital - University Medical Center
Camden, New Jersey, 08103
United States
Virtua Health
Marlton, New Jersey, 08053
United States
Valley Hospital
Paramus, New Jersey, 07652
United States
Lovelace Medical Center
Albuquerque, New Mexico, 87102
United States
Northwell Health
Bay Shore, New York, 11706
United States
Kaleida Health
Buffalo, New York, 14203
United States
New York University Medical Center
New York, New York, 10016
United States
Montefiore Medical Center
The Bronx, New York, 10467
United States
Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
United States
Rex Hospital
Raleigh, North Carolina, 27607
United States
Wake Medical Center
Raleigh, North Carolina, 27610
United States
Bethesda North Hospital-Hospital
Cincinnati, Ohio, 45242
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
Ohio State University Medical Center
Columbus, Ohio, 43210
United States
Legacy Emanuel Hospital & Health Center
Portland, Oregon, 97227
United States
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, 17101
United States
Trident Medical Center
Charleston, South Carolina, 29406
United States
Prisma Health
Columbia, South Carolina, 29203
United States
MUSC Health Columbia Medical Center Downtown
Columbia, South Carolina, 29204
United States
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
United States
St. Thomas Heart
Nashville, Tennessee, 37203
United States
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
United States
Memorial Hermann Memorial City Medical Center
Houston, Texas, 77024
United States
Orion Medical
Houston, Texas, 77034
United States
Methodist Hospital
San Antonio, Texas, 78229
United States
Christus Trinity Mother Frances Health System-Hospital
Tyler, Texas, 75702
United States
St. Mark's Hospital
Salt Lake City, Utah, 84124
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States
Chippenham & Johnston-Willis Hospital
Richmond, Virginia, 23235
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States
Monongalia General Hospital
Morgantown, West Virginia, 26505
United States
Bellin Health
Green Bay, Wisconsin, 54305
United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Boston Scientific Corporation

  • Vivek Reddy, MD, STUDY_CHAIR, Icahn School of Medicine at Mount Sinai
  • Saibal Kar, MD, PRINCIPAL_INVESTIGATOR, Los Robles Health System
  • Walid Saliba, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2027-01

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Stroke
  • Bleeding