ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology

Atrial Fibrillation Clinical Trial

— ASAP  

Official title:

ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851578
• Other study ID #: ST1056
• Status: Completed
• Phase: N/A
• First received: February 24, 2009
• Last updated: January 26, 2015
• Start date: January 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• paroxysma, persistent, or permanent non-vlavular atrial fibrillation

• contraindicated to warfarin

• eligible for clopidogrel, ticlopdine, heparin, or aspirin

• CHADS score 1 or greater

Exclusion Criteria:

• NYHA Class IV

• LAA obliteration

• Heart transplant

• LVEF less than 30%

• greater than 50% carotid stenosis

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• WATCHMAN
WATCHMAN LAA Closure Device

Locations

Country	Name	City	State
Czech Republic	NA Homolce Hospital	Prague
Germany	Sankt Katharinen Hospital / Cardiovasculares Centrum	Frankfurt
Germany	Herzzentrum Leipzig	Leipzig
Germany	Chefarzt der Medizinischen Klinik III/Kardiologie	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment		2 years	No