An observational study in Stroke, Ischemic, Device Related Thrombosis and Atrial Fibrillation, sponsored by Aarhus University Hospital. Enrolling by invitation at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by Aarhus University Hospital · Observational
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.
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 931 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 300 across 777 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Watchman FLX implanted patients with a minimum of one early follow-up cardiac CT.
Inclusion Criteria:
Early (30-120 days) CT follow-up after Watchman FLX LAAO
Also known as: left atrial appendage closure, LAAO, LAAC
Ischemic stroke
Clinically affirmed ischemic stroke
Time frame: Minimum 12 months
Device-related thrombosis
High-grade hypoattenuated thickening as seen on cardiac CT
Time frame: Minimum 12 months
Major bleeding
BARC \>=2
Time frame: Minimum 12 months
All-cause and cardiovascular mortality
As defined in the Munich consensus
Time frame: Minimum 12 months
Plan to share: No — Patient data will be registered under a pseudonymous registry-ID and will not be personally identifiable.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Aarhus University Hospital