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APPEND-CT Registry

A

Aarhus University Hospital

Status

Invitation-only

Conditions

Atrial Fibrillation
Device Related Thrombosis
Stroke, Ischemic

Treatments

Device: Watchman FLX left atrial appendage occlusion

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT06213285
ISRCAR00442

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Watchman FLX LAAO
  • A minimum of one follow-up cardiac CT performed within 30-120 days post-procedure.
  • A minimum of one year clinical follow-up data

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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