Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG
NCT ID: NCT00273195
Last Updated: 2006-10-13
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
500 participants
INTERVENTIONAL
2004-04-30
2005-06-30
Brief Summary
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The purpose of this study was to evaluate the safety and efficacy of the EnTrust ICD device. A feature of this device allows it to send small, painless electrical impulses (Anti-tachycardia pacing or ATP) to the heart instead of shocking it out of a rhythm that is too fast. Stopping a dangerous heart rhythm this way does not cause any pain whereas a shock to the heart can feel like a punch in the chest. This device also allows the heart to beat on its own when it can and helping it (by pacing, or sending it electrical signals) when it needs help. This feature is important because previously studies have shown that pacing the heart too often can increase the risk for heart failure or for atrial fibrillation (having too rapid of heart beats in the atrium).
This study is now complete and the device has since been approved by the FDA.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Implantable Cardioverter Defibrillator
Eligibility Criteria
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Inclusion Criteria
Subjects who have, or are risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD)
Subjects who have, or are at risk of developing, rapid beats in the upper chambers of the heart (atrial tachyarrhythmias)
Exclusion Criteria
Subjects with mechanical tricuspid heart valves (A structure in the heart, located between the right atrium and right ventricle, which allows blood to flow down from the atrium into the ventricle.)
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Locations
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Little Rock, Arkansas, United States
Glendale, California, United States
Inglewood, California, United States
Atlantis, Florida, United States
Orlando, Florida, United States
Macon, Georgia, United States
Fort Wayne, Indiana, United States
Davenport, Iowa, United States
Des Moines, Iowa, United States
Salisbury, Maryland, United States
Boston, Massachusetts, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Abington, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Richmond, Virginia, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Sankt Pölten, , Austria
Steyr, , Austria
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Kingston, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
Copenhagen, , Denmark
Bonn, , Germany
Göttingen, , Germany
Heidelberg, , Germany
Kaiserslautern, , Germany
München, , Germany
Münster, , Germany
Eindhoven, , Netherlands
Basel, , Switzerland
Countries
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Other Identifiers
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213
Identifier Type: -
Identifier Source: org_study_id