APPEND-CT Registry

NCT06213285 | Enrolling By Invitation FDA Device

• 1 other identifier: ISRCAR00442
• Study Type: observational
• Target: 2,000
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Stroke, Ischemic; Device Related Thrombosis; Atrial Fibrillation

Keywords

Left Atrial Appendage Occlusion; Cardiac Computed Tomography; Watchman FLX

Outcome Measures

Primary Outcomes (1)

• Ischemic stroke

  Clinically affirmed ischemic stroke

  Minimum 12 months

Secondary Outcomes (3)

• Device-related thrombosis

  Minimum 12 months

• Major bleeding

  Minimum 12 months

• All-cause and cardiovascular mortality

  Minimum 12 months

Interventions

Watchman FLX left atrial appendage occlusion DEVICE

Early (30-120 days) CT follow-up after Watchman FLX LAAO

Also known as: left atrial appendage closure, LAAO, LAAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Watchman FLX implanted patients with a minimum of one early follow-up cardiac CT.

You may qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Mayo Clinic: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Ischemic Stroke; Atrial Fibrillation

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Anders Kramer, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-fellow

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: February 14, 2024
• Primary Completion: August 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); DK (1)