Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG
1 other identifier
interventional
500
7 countries
41
Brief Summary
People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2004
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 4, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedOctober 13, 2006
October 1, 2006
January 4, 2006
October 11, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and efficacy at three months.
Secondary Outcomes (3)
To evaluate how well the device distinguished between arrhythmias originating in the atrium versus those that originate in the ventricle.
To evaluate how well the anti-tachycardia pacing function works.
To observe the overall performance of the device system.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with failure but no symptoms (NYHA Class I) or subjects with mild heart failure that only sometimes interferes with daily activities (NYHA Class II)
- 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)
You may not qualify if:
- Subjects with rapid heart beats in their ventricles (lower chambers of the heart) associated only with reversible causes
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Little Rock, Arkansas, United States
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Glendale, California, United States
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Inglewood, California, United States
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Atlantis, Florida, United States
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Orlando, Florida, United States
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Macon, Georgia, United States
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Fort Wayne, Indiana, United States
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Davenport, Iowa, United States
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Des Moines, Iowa, United States
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Salisbury, Maryland, United States
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Boston, Massachusetts, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Abington, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Richmond, Virginia, United States
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Morgantown, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Sankt Pölten, Austria
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Steyr, Austria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Kingston, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Copenhagen, Denmark
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Bonn, Germany
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Göttingen, Germany
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Heidelberg, Germany
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Kaiserslautern, Germany
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München, Germany
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Münster, Germany
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Eindhoven, Netherlands
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Basel, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 4, 2006
First Posted
January 9, 2006
Study Start
April 1, 2004
Study Completion
June 1, 2005
Last Updated
October 13, 2006
Record last verified: 2006-10