RECRUITING

SIMPLAAFY Clinical Trial

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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: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 Criteria	Exclusion Criteria
* 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.	* 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. * 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.). * 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. * Subject has an active bleed. * Subject has a cardiac tumor. * Subject has signs/symptoms of acute or chronic pericarditis. * Subject has an active infection. * There is evidence of tamponade physiology. * Subject has New York Heart Association Class IV congestive heart failure at the time of implant or prior to randomization. * 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. * Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study. * Subject has a documented life expectancy of less than 12 months.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.
* 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.).
* 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.
* Subject has an active bleed.
* Subject has a cardiac tumor.
* Subject has signs/symptoms of acute or chronic pericarditis.
* Subject has an active infection.
* There is evidence of tamponade physiology.
* Subject has New York Heart Association Class IV congestive heart failure at the time of implant or prior to randomization.
* 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.
* Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.
* Subject has a documented life expectancy of less than 12 months.

Contacts and Locations

Study Contact

Holly Burtch

CONTACT

1-800-CARDIAC

holly.burtch@bsci.com

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)

Tucson Medical Center Healthcare

Tucson, Arizona, 85712

United States

Arrhythmia Research Group

Jonesboro, Arkansas, 72401

United States

Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360

United States

Christus Trinity Mother Frances Health System-Hospital

Tyler, Texas, 75702

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