Clinical Trials Logo
  1. Home
  2. Non-valvular Atrial Fibrillation
  3. NCT03088072

A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure

Non-Valvular Atrial Fibrillation Clinical Trial

Official title:
A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure

Clinical Trial Summary

This is a single arm, open label, single site study assessing the feasibility of post-procedural edoxaban therapy in atrial fibrillation (AF) patients after clinically indicated WATCHMAN left atrial appendage (LAA) closure.

Clinical Trial Description

This is a single site, PI initiated pilot study. This study will enroll up to 75 patients who are clinically indicated for a Left Atrial Appendage (LAA) closure with the commercially available WATCHMAN device. Subjects will be enrolled if they meet study inclusion/exclusion criteria and have a successful LAA closure. All patients enrolled in the study will receive 6 weeks of edoxaban therapy. At 6 weeks post LAA closure a Transesophageal Echocardiography (TEE) will be performed. If the result is acceptable, edoxaban will be discontinued and the patient will be treated with dual antiplatelet therapy (aspirin and clopidogrel) until 6 month follow-up. After study completion, patients may be treated with aspirin monotherapy according to the FDA instructions for use for the WATCHMAN device, or according to operator discretion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03088072
Study type Interventional
Source Scripps Health
Contact Catchpole Heather
Phone 858 824 4248
Email Catchpole.Heather@scrippshealth.org
Status Recruiting
Phase Phase 4
Start date March 23, 2017
Completion date December 31, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
Withdrawn NCT03508258 - Study to Describe Risk of Bleeding in Patients Depending on the Different Anticoagulant Therapy They Are on for Atrial Fibrillation (AF)
Terminated NCT03715725 - A Nationwide Observational Study Looking at Effectiveness and Bleeding Complications of NOACs vs. VKA in Non-valvular Atrial Fibrillation Patients.
Active, not recruiting NCT05565599 - An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation N/A
Completed NCT02756481 - Local Adaptation of Cost Effectiveness Model for Apixaban Atrial Fibrillation Indication - Venezuela N/A
Completed NCT04193826 - The Conformal Prague Study N/A
Completed NCT01884350 - Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN) Phase 4
Completed NCT02422602 - Better Adherence With New Oral Anticoagulant in Atrial Fibrillation : Effectiveness of a Personalized Education Program N/A
Recruiting NCT02147444 - Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic Embolism in a Nationwide Cohort of Japanese Patients Diagnosed as Non-valvular Atrial Fibrillation N/A
Completed NCT01857622 - Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment Phase 3
Recruiting NCT04829929 - Evaluation od Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk N/A
Recruiting NCT05761704 - Exploratory Observation of Two Short-term Regimens After LAA Occlusion by LAMax LAAC® Device for Subjects With Non-valvular Atrial Fibrillation N/A
Recruiting NCT04559243 - Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
Completed NCT03570047 - Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation
Terminated NCT03204695 - WAVECREST Post Market Clinical Follow-Up (PMCF) Study N/A
Completed NCT04722679 - A Study to Collect Information on the Characteristics of Elderly Belgian Patients With NVAF That Are Treated With a NOAC for This Indication With a Special Focus on Their Fear of Bleeding While Using a NOAC vs the Clinical Benefit of a NOAC of Thrombosis/Stroke Prevention.
Completed NCT04297072 - Study to Gather Information on the Kidney Function of Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem) Treated With Rivaroxaban or Vitamin K Antagonists
Recruiting NCT05320627 - Population Pharmacokinetics of Edoxaban in Chinese Patients With Non-Valvular Atrial Fibrillation Phase 4
Completed NCT04519944 - Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
Completed NCT02488421 - Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF2 N/A