Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Long Term Clinical Outcomes of Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation; From Korean Multicenter Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03108872
• Other study ID #: Ver 1.0_20170306
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2017
• Last updated: May 23, 2017
• Start date: May 23, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: May 2017
• Source: Sejong General Hospital
• Contact: Hyun Jong Lee, MD
• Phone: 82-10-6217-9315
• Email: untouchables[@]sejongh.co.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

We will compare long-term effectiveness and safety in patients with atrial fibrillation treated with left atrial appendage occlusion versus new oral anticoagulants to prevent ischemic stroke from multicenter registry data

Description:

Atrial fibrillation (AF) is associated with a substantial risk of stroke and systemic embolism. Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation and high risk of ischemic stroke. However, their use is limited by a narrow therapeutic range, increased risk of intracranial hemorrhage, the need for continuous monitoring of INR, and drug or food interaction. New oral anticoagulants (NOACs), the direct thrombin inhibitor and the factor Xa inhibitor, have settled these limitations of warfarin therapy. In four pivotal phase 3 clinical trials and their meta-analysis, NOACs have been shown to significantly reduce ischemic stroke, intracranial hemorrhage, and mortality, and had similar major bleeding as for warfarin in patients with non-valvular atrial fibrillation (NVAF). Another new treatment strategy for prevention of stroke is left atrial appendage occlusion (LAAO). Left atrial appendage has been considered to be an origin of thrombi more than 90% of cases. The concept that exclusion of LAA from the circulation reduces the risk of stroke in patients with NVAF is therefore being tested in clinical studies. LAAO with Watchman device and only aspirin were proved to be non-inferior to warfarin for ischemic stroke prevention or systemic embolism. And, LAAO reduced significantly cardiac death and hemorrhagic stroke compared to warfarin in a long-term follow up. Up to date, there was no study to compare long-term clinical outcomes between LAAO and NOACs, which are two new treatment strategies for stroke prevention in patients with NVAF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients with atrial fibrillation, who LAAO or NOAC to prevent ischemic stroke or systemic embolism

2. Patients with CHA2DS2-VASc score >1

Exclusion Criteria:

1. Patients who failed to successfully implant LAAO

2. Patients who receive new oral anticoagulant less than 6 months without clinical events

3. Patients with mitral stenosis more than mild grade

4. Patients with prosthetic heart valve

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• left atrial appendage occlusion
Percutaneous exclusion of left atrial appendage with Watchman or ACP devices

Drug:
• New oral anticoagulants
Include dabigatran, rivaroxaban, apixaban and edoxaban

Locations

Country	Name	City	State
Korea, Republic of	Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu	Bucheon	Gyeonggi

Sponsors (5)

Lead Sponsor	Collaborator
Sejong General Hospital	Gachon University Gil Medical Center, Korea University Anam Hospital, Ulsan University Hospital, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Kim JS, Lee H, Suh Y, Pak HN, Hong GR, Shim CY, Yu CW, Lee HJ, Kang WC, Shin ES, Choi RK, Kar S, Park JW, Lim DS, Jang Y. Left Atrial Appendage Occlusion in Non-Valvular Atrial Fibrillation in a Korean Multi-Center Registry. Circ J. 2016 Apr 25;80(5):1123-30. doi: 10.1253/circj.CJ-15-1134. Epub 2016 Mar 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary effectiveness endpoint	The composite of cardiovascular or unexplained death, or ischemic stroke, or systemic embolism	During 4 years
Primary	Primary safety endpoint	Major bleeding or Serious device-related complications	During 4 years
Secondary	Cardiovascular or unexplained death		During 4 years
Secondary	Ischemic stroke or systemic embolism		During 4 years
Secondary	Hemorrhagic stroke		During 4 years
Secondary	Major bleeding	Bleeding event that required at least 2 units of packed RBCs or Symptomatic bleeding in a critical area or organ.	During 4 years
Secondary	Serious device-related complications	Serious pericardial effusion need procedure or surgery, peri-procedural stroke, or device embolization	During 4 years