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

NCT ID: NCT06523166

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Left Atrial Appendage Occlusion (LAAC) with Watchman FLX.

Patients who are status post LAAC using the Watchman FLX.

Group Type: EXPERIMENTAL

Transesophageal echocardiography (TEE)

Intervention Type: 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.

Cardiac CTA

Intervention Type: 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.

Interventions

Transesophageal echocardiography (TEE)

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.

Intervention Type: PROCEDURE

Cardiac CTA

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Steven Filby, MD

Physician, Interventional Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Filby, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

Cedars Sinai

Los Angeles, California, United States

St. Francis Hospital and Catholic Health

Roslyn, New York, United States

Sanger Heart & Vascular Institute- Atrium Health

Charlotte, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Central Contacts

Amy McKnight, RN, BSN, BCCV

Role: CONTACT

Amy.McKnight@UHhospitals.org

216-983-4896

Facility Contacts

Rhona Littman

Role: primary

*Littmanr@cshs.org

310-423-4387

Elizabeth Haag, RN, MPA

Role: primary

Elizabeth.Hagg@chsli.org

516-622-4512

Dana Amaro, MSN, RN

Role: primary

Dana.Amaro@atriumhealth.org

704-355-4692

Amy McKnight, RN, BSN, BCCV

Role: primary

Amy.McKnight@UHhospitals.org

216-983-4896

Adrianne Miller, MS, CCRP

Role: primary

Adrianne.Miller3@osumc.edu

614-688-8252

Other Identifiers

STUDY20231491

Identifier Type: -

Identifier Source: org_study_id