NCT06075628 · Kansas City Heart Rhythm Research Foundation
Long-Term Outcomes of LAA Contrast Flow in CT Scans After Endocardial LAA Closure: The CF-CT Registry
What this study is about
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, reviewing past data study. Approximately 100 subject charts will be reviewed.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Overland Park, Kansas
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 28, 2025 · Source of record for eligibility and locations