Hemostatic Activity Following LAAO

NCT05011981 | Unknown DMC

• 1 other identifier: Hemo-LAAO
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (1)

• Change in coagulation activity

  Coagulation activity as measured by prothrombin fragment 1+2

  7 days, 14 days, 90 days

Secondary Outcomes (6)

• Change in platelet activity

  7 days, 14 days, 90 days

• Additional measures of changes in coagulation and contact activation

  7 days, 14 days, 90 days

• Change in endothelial activation and response

  7 days, 14 days, 90 days

• Non-procedural bleeding events

  7 days, 14 days, 90 days

• Radiographical evidence of device endothelization

  7 days, 14 days, 90 days

Interventions

Left Atrial Appendage Occlusion DEVICE

Interventional left atrial appendage occlusion with the Amulet or Watchman device

Also known as: Left Atrial Appendage Closure

Eligibility Criteria

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

Study Population

Only patients already eligible for LAAO will be screened by clinical personnel and potentially recruited for participation. Blood samples will be systematically sampled during planned follow-up timepoints.

You may qualify if:

• Age \> 18 years
• Atrial fibrillation (paroxysmal, persistent, or permanent)
• Admitted and eligible for LAAO
• Signed written consent

You may not qualify if:

• Known hereditary bleeding disorders (i.e. Hemophilia A and B, Von Willebrand disease)
• Platelet count \< 75 x 109/ml

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus N, Central Denmark, 8200, Denmark

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

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

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: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 18, 2021
• Study Start: October 11, 2021
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

DK (1)