Long-Term Outcomes of Left Atrial Appendage Contrast Flow in CT Scans After Endocardial LAA Closure: The CF-CT Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief 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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Total time to complete endothelization or no LAA-CF(12 Months)
- Association of device size with LAA-CF(12 Months)
- Association of landing zone with LAA-CF(12 Months)