ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00851578

Acronym

ASAP

Enrollment

150

Registered

2009-02-26

Start date

2009-01-31

Completion date

2013-12-31

Last updated

2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

AF, atrial fibrillation, LAA occlusion

Brief 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.

Interventions

DEVICEWATCHMAN

WATCHMAN LAA Closure Device

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment	2 years

Countries

Czechia, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026