A Pilot Study to Assess WATCHMAN FLX™ Implants by Cardiac Computed Tomography, Magnetic Resonance Imaging and Transesophageal Echocardiography: WATCHMAN FLX™ CT

WATCHMAN FLX™ CT is a prospective, single-arm, single-center, post-market investigation to assess device tissue coverage in subjects with non-valvular atrial fibrillation (AF) who receive the WATCHMAN FLX device to reduce the risk of stroke. Serial advanced imaging modalities such as CT and TEE will be used.

Study Overview

• Status: Active, not recruiting
• Conditions: The Focus of the Study is to Reduce the Risk of Stroke and Life-threatening Bleeding Events in Patients With Non-valvular Atrial Fibrillation
• Intervention / Treatment: Device: Watchman FLX Device

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nilou Zilinek; Phone Number: 508-683-6127; Email: Nilou.Zilinek@bsci.com

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject is of legal age to participate in the study per the laws of their respective geography.
• Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
• Subject is clinically indicated for a WATCHMAN FLX device.
• Subject is deemed suitable for the protocol-defined pharmacologic regimen.
• Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.
• Subject is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:

• 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 has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).
• Subject is contraindicated for TEE.
• Subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction (e.g., due to an underlying hypercoagulable state).
• Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.).
• Subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 30 days prior to enrollment.
• Subject had a prior major bleeding event per ISTH definitions within the 30 days prior to enrollment. 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 reversible cause for AF or has transient AF.
• Subject has no LAA or the LAA is surgically ligated.
• Subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to enrollment.
• Subject has a history of atrial septal repair or has an atrial septal defect/patent foramen ovale (ASD/PFO) device.
• Subject has a known contraindication to percutaneous catheterization procedure.
• 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 enrollment.
• Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).
• Subject has a documented life expectancy of less than 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Arm; WATCHMAN FLX™ device implantation	Device: Watchman FLX Device; Left atrial appendage closure using the Watchman FLX device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device tissue coverage	• Device surface morphology (inclusive of tissue coverage) post implant procedure as assessed over time using the serial advanced imaging modalities of cardiac computed tomography (CT) and transesophageal echocardiography (TEE)	14, 45 and 90 days post-implant

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Jens Erik Nielsen-Kudsk, MD, Aarhus University Hospital Skejby

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: S2423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No