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

ConditionsAtrial FibrillationIschemic Stroke, Acute
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKansas City Heart Rhythm Research Foundation

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Left Atrial Appendage Occlusion

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Amplatzer Amulet1 intervention
Group B: Watchman / Watchman FLX1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
12 Months

Secondary outcomes

1

Total time to complete endothelization or no LAA-CF

Total time to complete endothelization or no LAA-CF will be assessed.

Time frame
12 Months
2

Association of device size with LAA-CF

Association of device size with LAA-CF will be assessed.

Time frame
12 Months
3

Association of landing zone with LAA-CF

Association of landing zone with LAA-CF will be assessed.

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kansas City Heart Rhythm Research Foundation

Lead sponsor

Source ClinicalTrials.gov
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