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Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Boston Scientific Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01196897
First received: August 16, 2010
Last updated: September 23, 2013
Last verified: August 2012

August 16, 2010
September 23, 2013
May 2009
September 2012   (final data collection date for primary outcome measure)
  • Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure. [ Time Frame: 12-Months ] [ Designated as safety issue: Yes ]
    The implantation of the next generation WATCHMAN device without the occurrence of life-threatening events caused by the device and/or the procedure. These events may include device embolization requiring retrieval, bleeding events such as pericardial effusion requiring drainage, cardiac perforation requiring operation, cranial bleeding events due to any source, and any systemic embolic events related to the device or procedure.
  • Device Success [ Time Frame: Implant through 45-Days ] [ Designated as safety issue: No ]
    Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary.
Same as current
Complete list of historical versions of study NCT01196897 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)
Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients

This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • Device: WATCHMAN LAA Closure Technology
    Implantation of the WATCHMAN device into the left atrial appendage.
  • Device: WATCHMAN Left Atrial Appendage Closure Device
Experimental: Implantable device
Interventions:
  • Device: WATCHMAN LAA Closure Technology
  • Device: WATCHMAN Left Atrial Appendage Closure Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
September 2013
September 2012   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Paroxysmal, persistent, or permanent non-valvular atrial fibrillation
  • Eligible for long-term Warfarin therapy;
  • Eligible to come off Warfarin therapy if the LAA is sealed
  • Calculated CHADS2 score of 1 or greater

Key Exclusion Criteria:

  • New York Heart Association Class IV Congestive Heart Failure
  • Recent MI (within 3 months)
  • ASD and/or atrial septal repair or closure device
  • Resting heart rate >110 bpm
  • Has an implanted mechanical valve prosthesis
  • Left atrial appendage is obliterated
  • Has undergone heart transplantation
  • Has symptomatic carotid disease
  • Contraindicated for aspirin
  • LVEF < 30%
  • Cardiac Tumor
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany
 
NCT01196897
CT1000
Yes
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Not Provided
Boston Scientific Corporation
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP