Watchman FLX Pro CT Pilot Study

NCT05567172 | Completed Results

• 1 other identifier: S2517
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to measure device tissue coverage post-implantation of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device (WATCHMAN FLX Pro) using the serial advanced imaging modalities of cardiac computed tomography (CT) and transesophageal echocardiography (TEE) and assess its relationship, if any, to clinical events.

Conditions

Non-valvular Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device

  Serial measurement of any HAT on the surface of the device at 14 days, 45 days and 3 months post implant as assessed by core lab using CT imaging

  14 days to 3 months post implant

Study Arms (1)

Watchman FLX Pro

EXPERIMENTAL

Device: Left atrial appendage closure device WM FLX Pro

Interventions

Left atrial appendage closure device WM FLX Pro DEVICE

Left atrial appendage closure

Watchman FLX Pro

Eligibility Criteria

• Age: 18 Years - 90 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 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 Pro 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.

You may not qualify if:

• 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 TIA within the 30 days prior to enrollment.
• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

Location

Results Point of Contact

• Title: Nilou Zilinek
• Organization: Boston Scientific

nilou.zilinek@bsci.com

5086836127

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 5, 2022
• Study Start: March 24, 2023
• Primary Completion: October 14, 2024
• Study Completion: June 18, 2025
• Last Updated: December 9, 2025
• Results First Posted: December 9, 2025

Record last verified: 2025-12

Locations

DK (1)