Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics

NCT06523166 | Not Yet Recruiting DMC

• 1 other identifier: STUDY20231491
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 5

Brief Summary

The current standard of care for patients who underwent left atrial appendage closure (LAAC) is to have follow-up transesophageal echocardiogram (TEE) for device surveillance. TEE is an ultrasound of the heart done by placing a probe in the esophagus under conscious sedation. It does not use contrast but can be cumbersome to patients as it involves placing a probe in the esophagus. Cardiac computerized tomography angiography (cardiac CTA) is a non-invasive imaging modality that involves the use of certain types of x-rays, contrast (dye) and special computers to generate accurate images of the heart. Participants in this study will undergo both TEE and CTA on the same day 90 days after their LAAC procedure. Participants will be in this research study for a period of 1 year, starting from the day of their scheduled LAAC procedure. Participants will undergo a TEE at 90 days after their procedure which is the standard of care imaging study after LAAC. As part of this study, participants will also undergo a cardiac CTA at 90 days as well. Participants will have a routine follow-up visit following device placement as per standard of care as well as a brief phone "check in" at 1 year.

Conditions

Device Related Thrombosis; Peri-device Leak

Keywords

Watchman FLX; Left atrial appendage (LAA); Transesophageal echocardiography (TEE); Cardiac CTA

Outcome Measures

Primary Outcomes (4)

• LAA patency percentage associated with peri device leak (PDL) as measured by CT scan/TEE

  3 months post procedure

• LAA patency percentage associated with intra device leak (IDL) as measured by CT scan/TEE.

  3 months post procedure

• LAA patency percentage associated with a combination of both PDL and IDL as measured by CT scan/TEE.

  3 months post procedure

• Number of detected device-related thrombus (DRT) as measured by CT scan/TEE.

  3 months

Secondary Outcomes (5)

• Average size of device measured in millimeters (mm)

  3 months

• Percent of compression as measured by CT scan/TEE

  3 months

• Average depth of implant measured in millimeters (mm)

  3 months

• Average hypo-attenuated thickening (HAT) measured in millimeters (mm)

  3 months

• Number of adverse events as measured by medical record

  Up to 7 days

Study Arms (1)

Left Atrial Appendage Occlusion (LAAC) with Watchman FLX.

EXPERIMENTAL

Patients who are status post LAAC using the Watchman FLX.

Procedure: Transesophageal echocardiography (TEE); Procedure: Cardiac CTA

Interventions

Transesophageal echocardiography (TEE) PROCEDURE

TEE will be performed using a 3D probe. TEE images will be acquired at the standard 0, 45, 90, and 135 degree views along with a 3D acquisition encompassing the entire LAA, device, left pulmonary vein and lateral mitral annular landmarks.

Left Atrial Appendage Occlusion (LAAC) with Watchman FLX.

Cardiac CTA PROCEDURE

Cardiac CTA will be performed with ECG gating using systems with ≥ 64 detector rows and with temporal resolution that is at least 175 msec (rotation speed ≤ 350 msec for single source systems). Cardiac CTA images will be acquired for the entire cardiac cycle without ECG phase specific pulsing and with contrast appropriately timed for peak left atrial/arterial phase contrast enhancement. In addition, a targeted end systolic only delayed phase image set (45 seconds after the arterial phase scan and limited to the left atrium and appendage device) will be acquired.

Left Atrial Appendage Occlusion (LAAC) with Watchman FLX.

Eligibility Criteria

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

You may qualify if:

• Subjects \>18 years old planned to undergo LAAC
• eGFR ≥ 30 mL/min per 1.73 m2

You may not qualify if:

• Subjects below the age of 18
• non-English speaking subjects
• eGFR \< 30 mL/min per 1.73 m2
• Subjects with history of contrast allergy
• Pregnant women

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Boston Scientific Corporation: collaborator

Study Sites (5)

Cedars Sinai

Los Angeles, California, 90048, United States

Location

St. Francis Hospital and Catholic Health

Roslyn, New York, 11576, United States

Location

Sanger Heart & Vascular Institute- Atrium Health

Charlotte, North Carolina, 28277, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Study Officials

• Steven Filby, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy McKnight, RN, BSN, BCCV

CONTACT

216-983-4896; Amy.McKnight@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Interventional Cardiology

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: December 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)