Status:
COMPLETED
InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
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
- Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined the need for an implantable cardioverter defibrillator.
- Subject is on optimal medical treatment for heart failure.
- Subject has reduced left ventricular ejection fraction (LVEF≤35%). (LVEF is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the LVEF the more blood the ventricle is pumping.)
- Subject who has heart failure which severely limits daily activities (NYHA Class III) or subject who has severe heart failure and should always be resting (NYHA Class IV)
- Subject who has a QRS≥130ms (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels/conducts through the ventricles. A wide QRS (more than 120 ms) suggests that there is a conduction problem (or block) in the ventricles.)
- Subjects with a left ventricular end diastolic dimension (LVEDD≥55mm). (The LVEDD is a measurement taken during an echocardiogram that is one indication of the health of the left ventricle.)
Exclusion
- Subject has unstable chest pain, heart surgery within past 3 months
- Subject has liver function tests greater than 3 times normal limits
- Subject has chronic (permanent) atrial arrhythmias (fast heart beats in the upper chamber(s) of the heart)
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00271232
Start Date
March 1 2003
End Date
April 1 2005
Last Update
December 21 2007
Active Locations (34)
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1
Anchorage, Alaska, United States
2
Phoenix, Arizona, United States
3
Los Angeles, California, United States
4
Stanford, California, United States