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OpenTrials
Completed

NCT Number: NCT00851578

ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NA Homolce Hospital, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WATCHMAN

Device

WATCHMAN LAA Closure Device

Primary outcomes

  1. Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: ASAP

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Feb 26, 2009
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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