APPEND-CT Registry — APPEND-CT  

Atrial Fibrillation Clinical Trial

Official title: Cardiac Computed Tomography Following Watchman FLX Left Atrial APPENDage Closure

Status Enrolling by invitation

Clinical Trial Summary

The APPEND-CT registry is an investigator-driven multicenter retrospective observational database intended to compile cardiac CT follow-up data after Watchman FLX device implantation and function as a platform for answering clinical and research questions within LAAC follow-up. The derived studies should support therapeutic decision-making, improve risk-stratification in LAAC and help generate hypotheses for potential future clinical intervention trials.

Clinical Trial Description

An investigator-driven multicenter retrospective observational database enrolling patients from high-volume North American and European centers. The database will include Watchman FLX implanted patients with a minimum of one follow-up cardiac CT performed within 45-120 days post-procedure. Additional timepoints may be entered. Cardiac CT scans are to be uploaded and will be analyzed by the core-lab at Aarhus University Hospital.

Investigator-reported findings will be systematically reported to the database. This includes information on baseline characteristics, preprocedural planning, implantation details, discharge medication, follow-up imaging and clinical endpoints of interest.

As a minimum, investigator-reported endpoints will be collected from patient registries at one-year follow-up by site-investigators. Endpoints of interest include ischemic stroke, systemic embolism, major bleeding, mortality, device-related thrombosis, pericardial effusion, vascular complications, and device migration. ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Ischemic Stroke
• Stroke, Ischemic
• Thrombosis

• NCT number: NCT06213285
• Study type: Observational
• Source: University of Aarhus
• Status: Enrolling by invitation
• Start date: February 14, 2024
• Completion date: January 2025