Status:
COMPLETED
Attain StarFix™ Model 4195 Left Ventricular Lead
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
People who have abnormal heart beats, or whose heart does not beat on its own, may need an electronic device called a pacemaker or a defibrillator. Furthermore, people whose hearts have a reduced pump...
Eligibility Criteria
Inclusion
- QRS \> 130 ms (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. A wide QRS (more than 120) suggests that there is a conduction problem, or block, in the ventricles.)
- Left Ventricular Ejection Fraction (EF) \< 35% (Ejection Fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the EF the more blood the ventricle is pumping.)
- Subject has moderate to severe heart failure despite medications
Exclusion
- Subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt
- Subjects with chest pain or who have had a heart attack within the past month before enrollment in the study
- Subjects that have had certain surgeries on their heart within the past three months
- Subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT00269230
Start Date
July 1 2004
End Date
July 1 2005
Last Update
November 20 2008
Active Locations (25)
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1
Long Beach, California, United States
2
Palo Alto, California, United States
3
Newark, Delaware, United States
4
Jacksonville, Florida, United States