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

Conditions

• Atrial Fibrillation
• Ischemic Stroke, Acute

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Left Atrial Appendage Occlusion — OTHER
  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.

Study Details

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.

Key Dates

Start date

Jul 24, 2023

Status verified

Aug 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: Amplatzer Amulet
  This is the group of subjects who are implanted with Amplatzer Amulet device.
• Arm: Watchman / Watchman FLX
  This is the group of subjects who are implanted with Watchman / Watchman FLX device.

Primary Outcome Measure

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 ]

Central Contacts

• Donita Atkins
  816-651-1969
  [email protected]

Locations (1)

Find similar trials in Overland Park, KS

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