APPEND-CT Registry

Atrial Fibrillation Clinical Trial

— APPEND-CT  

Official title:

Cardiac Computed Tomography Following Watchman FLX Left Atrial APPENDage Closure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06213285
• Other study ID #: ISRCAR00442
• Status: Enrolling by invitation
• Start date: February 14, 2024
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: January 2025
• Est. primary completion date: August 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Watchman FLX left atrial appendage occlusion
Early (30-120 days) CT follow-up after Watchman FLX LAAO

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital	Boston Scientific Corporation, Mayo Clinic

Countries where clinical trial is conducted

United States,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic stroke	Clinically affirmed ischemic stroke	Minimum 12 months
Secondary	Device-related thrombosis	High-grade hypoattenuated thickening as seen on cardiac CT	Minimum 12 months
Secondary	Major bleeding	BARC >=2	Minimum 12 months
Secondary	All-cause and cardiovascular mortality	As defined in the Munich consensus	Minimum 12 months