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

Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics: A Multicenter Study

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.

Study Overview

• Status: Recruiting
• Conditions: Device Related Thrombosis; Peri-device Leak
• Intervention / Treatment: Procedure: Transesophageal echocardiography (TEE); Procedure: Cardiac CTA

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy McKnight, RN, BSN, BCCV; Phone Number: 216-983-4896; Email: Amy.McKnight@UHhospitals.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Not yet recruiting
      • Cedars Sinai
      • Contact: Rhona Littman; Phone Number: 310-423-4387; Email: *Littmanr@cshs.org
      • Principal Investigator: John Friedman, MD
  • New York
    • Roslyn, New York, United States, 11576
      • Not yet recruiting
      • St. Francis Hospital and Catholic Health
      • Contact: Elizabeth Haag, RN, MPA; Phone Number: 516-622-4512; Email: Elizabeth.Hagg@chsli.org
      • Principal Investigator: Omar Khlaique, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Recruiting
      • Sanger Heart & Vascular Institute- Atrium Health
      • Contact: Dana Amaro, MSN, RN; Phone Number: 704-355-4692; Email: Dana.Amaro@atriumhealth.org
      • Principal Investigator: Markus Scherer, MD
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • University Hospitals Cleveland Medical Center
      • Principal Investigator: Steven Filby, MD
      • Contact: Amy McKnight, RN, BSN, BCCV; Phone Number: 216-983-4896; Email: Amy.McKnight@UHhospitals.org
    • Columbus, Ohio, United States, 43210
      • Not yet recruiting
      • Ohio State University Medical Center
      • Contact: Adrianne Miller, MS, CCRP; Phone Number: 614-688-8252; Email: Adrianne.Miller3@osumc.edu
      • Principal Investigator: Mahmoud Houmssee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• 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: Left Atrial Appendage Occlusion (LAAC) with Watchman FLX.; Patients who are status post LAAC using the Watchman FLX.

Procedure: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average size of device measured in millimeters (mm)		3 months
Percent of compression as measured by CT scan/TEE	Percent compression is comprised by dividing the device diameter over the device size represented as one single score.	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	Adverse events can include respiratory failure requiring intubation or an esophageal perforation from TEE probe insertion or serious contrast related event including anaphylaxis during the CTA or acute renal failure (ARF) requiring dialysis within 7 days of the CTA.	Up to 7 days

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Steven Filby, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Left atrial appendage (LAA); Cardiac CTA; Watchman FLX; Transesophageal echocardiography (TEE)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: STUDY20231491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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