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Completed

NCT Number: NCT00129545

WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Ischemic Attack, Transient Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Na Homolce, Prague, Czechia

Loading trial locations.

About this study

The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
  • Eligible for long term warfarin
  • CHADS score >= 1 [congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)]

Exclusion criteria

  • Contraindicated for warfarin
  • Contraindicated for aspirin or clopidogrel (Plavix)
  • Congestive heart failure (CHF) Class 4
  • Implanted mechanical valve
  • Atrial septal or Patent Foramen Ovale (PFO) device
  • Platelets < 100,000 or hemoglobin < 10
  • Left ventricular ejection fraction (LVEF) < 30%

Treatment and study plan

WATCHMAN Left Atrial Appendage Closure Technology

Device

Implant of WATCHMAN Left Atrial Appendage Closure Technology

Other names: WATCHMAN

Warfarin

Drug

Subjects receive warfarin

Other names: Coumadin

Primary outcomes

  1. Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death

    Time frame: 5 years

    A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years)

  2. The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events

    Time frame: 5 years

    Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.

Secondary outcomes

  1. Procedure Success

    Time frame: Initial implant procedure

    Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

Important dates

Study start
2005
Primary completion
2013
Study completion
2014
First posted
Aug 12, 2005
Registry last updated
May 15, 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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