Long-Term Outcomes of LAA Contrast Flow in CT Scans After Endocardial LAA Closure: The CF-CT Registry

August 27, 2025 updated by: Kansas City Heart Rhythm Research Foundation

Long-Term Outcomes of Left Atrial Appendage Contrast Flow in CT Scans After Endocardial LAA Closure: The CF-CT Registry

This study is intended to assess the incidence and correlation to the development of peri-device leaks (PDLs), device related thrombosis (DRTs) and cerebral vascular accident (CVA)/transient ischemic attacks (TIAs) in association with left atrial appendage contrast flow (LAA-CF). It will be a multi-center, retrospective study. Approximately 100 subject charts will be reviewed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Although the clinical significance of long-term left atrial appendage contrast flow (LAA-CF) in computerized tomography (CT) scan is unknown, study by Lim et al reported that 45 days are not enough for complete left atrial appendage (LAA) seal-off after left atrial appendage occlusion (LAAO) in humans and anatomic closure may not necessarily ensure treatment success. Long-term monitoring is warranted in high-risk patients with LAAO after switching from anticoagulation to antiplatelet therapy. They reported possible explanations for residual LAA-CF after LAAO to be related to peri-device gaps, incomplete endothelialization on the device surface, an off-axis device, fabric leak through the non-endothelialized portion of the device.

To this date no studies or registries exist on long term follow up and association of Left Atrial Appendage Contrast Flow (LAA-CF). In this study with two FDA approved devices (Watchman/Watchman FLX and Amplatzer Amulet), it is hypothesized that the LAA contrast-flow (CF) rate is related to lack of endothelization of the implanted devices and potentially associated with peri-device leaks (PDLs), device related thrombosis (DRT).

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Kansas City Heart Rhythm Institute
        • Principal Investigator:
          • Dhanunjaya Lakkireddy, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Charts of all subjects who underwent LAA closure either with Watchman/Watchman FLX or Amplatzer Amulet device from January 2019 till June 2022 will be reviewed.

Chart review will be performed up to 1 year, after the patient is discharged from the hospital.

Description

Inclusion Criteria:

  • Subjects must be at least 18 years of age.
  • Subjects underwent LAA closure with Watchman/Watchman FLX or Amplatzer Amulet at our institution from January 2019 till June 2022

Exclusion Criteria:

  • No definite exclusion criteria are defined for the study as all patients with Watchman-FLX or Amplatzer Amulet will be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Amplatzer Amulet
This is the group of subjects who are implanted with Amplatzer Amulet device.
Other: Left Atrial Appendage Occlusion
Acute ischemic stroke is a major cause of morbidity and mortality in non-valvular Atrial Fibrillation (AF). Oral Anticoagulation (OAC) with Warfarin and Direct oral anticoagulants (DOACs) has been the mainstay to prevent systemic thromboembolism (STE) in this patient population. It is estimated that around 50% of patients who have AF with indication for OAC end up being not on OAC due to bleeding complications leaving them at high risk for developing STE. Left atrial appendage occlusion (LAAO) offers an option in such population.
Watchman / Watchman FLX
This is the group of subjects who are implanted with Watchman / Watchman FLX device.
Other: Left Atrial Appendage Occlusion
Acute ischemic stroke is a major cause of morbidity and mortality in non-valvular Atrial Fibrillation (AF). Oral Anticoagulation (OAC) with Warfarin and Direct oral anticoagulants (DOACs) has been the mainstay to prevent systemic thromboembolism (STE) in this patient population. It is estimated that around 50% of patients who have AF with indication for OAC end up being not on OAC due to bleeding complications leaving them at high risk for developing STE. Left atrial appendage occlusion (LAAO) offers an option in such population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and correlation to the development of Peri-Device Leak (PDLs), Device-Related Thrombus (DRT) or cerebral vascular accident (CVA) in association with LAA-CF
Time Frame: 12 Months
Incidence and correlation to the development of PDLs, DRTs or CVA in association with LAA-CF will be assessed. These will be noted as either Yes or No.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total time to complete endothelization or no LAA-CF
Time Frame: 12 Months
Total time to complete endothelization or no LAA-CF will be assessed.
12 Months
Association of device size with LAA-CF
Time Frame: 12 Months
Association of device size with LAA-CF will be assessed.
12 Months
Association of landing zone with LAA-CF
Time Frame: 12 Months
Association of landing zone with LAA-CF will be assessed.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Research Foundation

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCHRRF_CF-CT Registry_0021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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