Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)
NCT ID: NCT01196897
Last Updated: 2015-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2009-05-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Implantable device
WATCHMAN LAA Closure Technology (Gen 4.0)
WATCHMAN LAA Closure Technology (Gen 4.0)
Implantation of the WATCHMAN device into the left atrial appendage.
Interventions
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WATCHMAN LAA Closure Technology (Gen 4.0)
Implantation of the WATCHMAN device into the left atrial appendage.
Eligibility Criteria
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Inclusion Criteria
* Eligible for long-term Warfarin therapy;
* Eligible to come off Warfarin therapy if the LAA is sealed
* Calculated CHADS2 score of 1 or greater
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
Na Homolce Hospital
Locations
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NA Homolce Hospital
Prague, , Czechia
Krankenhaus der Barmherzige Bruder
Regensburg, Bavaria, Germany
Sankt Katharinen Hospital / Cardiovasculares Centrum
Frankfurt, , Germany
Countries
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Other Identifiers
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CT1000
Identifier Type: -
Identifier Source: org_study_id