RecruitingNCT06075628

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

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

Sponsor

Kansas City Heart Rhythm Research Foundation

Enrollment

100 participants

Start Date

Jul 24, 2023

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation Ischemic Stroke, Acute

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study is following patients who had their left atrial appendage (LAA) — a small pouch in the heart — sealed with a device to prevent blood clots and stroke. Researchers are looking at CT scan findings after the procedure to understand long-term outcomes. **You may be eligible if...** - You are 18 years old or older - You previously had a LAA closure procedure at the study institution using a Watchman, Watchman FLX, or Amplatzer Amulet device between January 2019 and June 2022 **You may NOT be eligible if...** - You did not have your procedure at this specific institution - Your procedure was outside the January 2019 to June 2022 timeframe - No strict exclusion criteria are defined — all qualifying patients may be included Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLeft 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.