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

Last updated: October 25, 2024
Sponsor: Kansas City Heart Rhythm Research Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Thrombosis

Chest Pain

Treatment

Left Atrial Appendage Occlusion

Clinical Study ID

NCT06075628
KCHRRF_CF-CT Registry_0021
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must be at least 18 years of age.

  • Subjects underwent LAA closure with Watchman/Watchman FLX or Amplatzer Amulet at ourinstitution from January 2019 till June 2022

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Left Atrial Appendage Occlusion
Phase:
Study Start date:
July 24, 2023
Estimated Completion Date:
December 31, 2024

Study 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).

Connect with a study center

  • Kansas City Heart Rhythm Institute

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Overland Park Regional Medical Center

    Overland Park, Kansas 66215
    United States

    Site Not Available

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