Status:
COMPLETED
Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Ventricular Arrhythmias
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.)
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00273195
Start Date
April 1 2004
End Date
June 1 2005
Last Update
October 13 2006
Active Locations (41)
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1
Little Rock, Arkansas, United States
2
Glendale, California, United States
3
Inglewood, California, United States
4
Atlantis, Florida, United States