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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01196897
First received: August 16, 2010
Last updated: December 7, 2015
Last verified: August 2012

August 16, 2010
December 7, 2015
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
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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.
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Interventional
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Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Device: WATCHMAN LAA Closure Technology (Gen 4.0)
Implantation of the WATCHMAN device into the left atrial appendage.
Experimental: Implantable device
WATCHMAN LAA Closure Technology (Gen 4.0)
Intervention: Device: WATCHMAN LAA Closure Technology (Gen 4.0)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
November 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
Not Provided
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Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Vivek Reddy, MD Na Homolce Hospital
Boston Scientific Corporation
August 2012

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