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
441 participants
INTERVENTIONAL
2004-07-31
2005-07-31
Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of the Attain StarFixTM Model 4195 Left Ventricular (LV) Lead. This particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle. It is also "steroid-eluting" which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted.
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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Pacing Lead
Left ventricular pacing lead
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Medtronic CRDM
Principal Investigators
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Stuart W Adler II, MD
Role: PRINCIPAL_INVESTIGATOR
St. Paul Heart Clinic
Locations
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Long Beach, California, United States
Palo Alto, California, United States
Newark, Delaware, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Lexington, Kentucky, United States
Grand Rapids, Michigan, United States
Saginaw, Michigan, United States
Saint Paul, Minnesota, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Newark, New Jersey, United States
Rochester, New York, United States
Durham, North Carolina, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Temple, Texas, United States
Milwaukee, Wisconsin, United States
Calgary, Alberta, Canada
Victoria, British Columbia, Canada
London, Ontario, Canada
Sainte-Foy, Quebec, Canada
Milan, , Italy
Countries
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Other Identifiers
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234
Identifier Type: -
Identifier Source: org_study_id