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Long-Term Outcomes of LAA Contrast Flow After Endocardial LAA Closure

This study is looking at the long-term effects of Left Atrial Appendage (LAA) closure devices, specifically Watchman/Watchman FLX and Amplatzer Amulet. These devices are used to prevent strokes in people with Atrial Fibrillation (an irregular heartbeat). Researchers want to see if contrast flow (LAA-CF) seen on CT scans after the procedure is linked to problems like peri-device leaks (PDLs - small gaps around the device), device-related clots (DRTs), or strokes (CVA). They will review charts of about 100 people who had LAA closure at their institution between January 2019 and June 2022. You could be eligible if you are at least 18 years old and had one of these LAA closure procedures during that time. The study aims to understand if LAA-CF is connected to these complications, measured at 12 months.

Study design
This is an observational study, meaning researchers will review existing medical records. It will include about 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, which includes complications like peri-device leaks, device-related clots, or strokes, will be measured at 12 months.

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NCT06075628

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

Recruiting
Not specifiedAges 18+Observational
Kansas City Heart Rhythm Research Foundation
~100 participants
Updated 2025-08-28 on ClinicalTrials.gov
What's tested:Left Atrial Appendage Occlusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 12 Months

Conditions

Atrial Fibrillation
Ischemic Stroke, Acute

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Atrial FibrillationIschemic Stroke

Where it's being run

1 sites across 1 states
Kansas1

Study leadership

  • Dhanunjaya Lakkireddy, MD · PRINCIPAL_INVESTIGATOR · Kansas City Heart Rhythm Institute

Who to contact

Donita Atkins
[email protected]
816-651-1969
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial 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-CF12 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.