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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Atritech
ClinicalTrials.gov Identifier:
NCT01196897
First received: August 16, 2010
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Atrial Fibrillation
 Device: WATCHMAN LAA Closure Technology

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Atritech:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: May 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: WATCHMAN LAA Closure Technology
    Implantation of the WATCHMAN device into the left atrial appendage.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196897

Locations
Czech Republic
NA Homolce Hospital
Prague, Czech Republic, 150 30
Germany
Krankenhaus der Barmherzige Bruder
Regensburg, Bayern, Germany, 93049
Sankt Katharinen Hospital / Cardiovasculares Centrum
Frankfurt, Germany, 60389
Sponsors and Collaborators
Atritech
  More Information

No publications provided

Responsible Party: Atritech
ClinicalTrials.gov Identifier: NCT01196897     History of Changes
Other Study ID Numbers: CT1000
Study First Received: August 16, 2010
Last Updated: August 1, 2012
Health Authority: Czech Republic: Ethics Committee
Germany: Ethics Commission

Keywords provided by Atritech:
Atrial fibrillation
Stroke
Warfarin
 Coumadin
TIA
Trans Ischemic Attack

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013