NCT06213285

APPEND-CT Registry

Cardiac Computed Tomography Following Watchman FLX Left Atrial APPENDage Closure

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Stroke, Ischemic
• Device Related Thrombosis
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Watchman FLX left atrial appendage occlusion	Early (30-120 days) CT follow-up after Watchman FLX LAAO

Timeline

• Start date: 2024-02-14
• Primary completion: 2024-08-01
• Completion: 2025-01-01
• First posted: 2024-01-19
• Last updated: 2024-05-30

Locations

2 sites across 2 countries: United States, Denmark

Regulatory

• FDA-regulated device study