Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Boston Scientific Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Watchman FLX left atrial appendage occlusion | Device | Early (30-120 days) CT follow-up after Watchman FLX LAAO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic stroke | Clinically affirmed ischemic stroke | Minimum 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related thrombosis | High-grade hypoattenuated thickening as seen on cardiac CT | Minimum 12 months |
| Major bleeding | BARC >=2 | Minimum 12 months |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Watchman FLX implanted patients with a minimum of one early follow-up cardiac CT.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anders Kramer, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55901 | United States | ||
| Aarhus University Hospital |
Patient data will be registered under a pseudonymous registry-ID and will not be personally identifiable.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000097546 | Left Atrial Appendage Closure |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
| All-cause and cardiovascular mortality | As defined in the Munich consensus | Minimum 12 months |
| Aarhus |
| 8200 |
| Denmark |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |