Study Results
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View full resultsBasic Information
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TERMINATED
NA
205 participants
INTERVENTIONAL
2007-01-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RV Mid-Septal Pacing
Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Medtronic Dual-Chamber Pacemaker
A Medtronic market-approved dual-chamber implantable pulse generator (IPG)
Medtronic SelectSecure 3830 Lead
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
RV Apical Pacing
Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
Medtronic Dual-Chamber Pacemaker
A Medtronic market-approved dual-chamber implantable pulse generator (IPG)
Medtronic SelectSecure 3830 Lead
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
Interventions
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Medtronic Dual-Chamber Pacemaker
A Medtronic market-approved dual-chamber implantable pulse generator (IPG)
Medtronic SelectSecure 3830 Lead
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
Eligibility Criteria
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Inclusion Criteria
* Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment
* Subjects greater than 18 yrs of age
* Subjects that are indicated for a dual chamber pacemaker
* Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle
Exclusion Criteria
* Subjects indicated for an implantable cardiac defibrillator (ICD)
* Subjects with permanent atrial fibrillation (AF)
* Subjects with expected managed ventricular pacing turned on
* Subjects with a previously implanted pacemaker, ICD, or CRT device
* Subjects with an myocardial infarction (MI) within 3 months prior to enrollment
* Subjects that received bypass surgery within 3 months prior to enrollment
* Subjects that had valve replacement within 3 months prior to enrollment
* Subjects where a RV lead cannot be placed, (i.e., complex congenital heart disease
* Subjects with a mechanical right heart valve
* Women who are pregnant or nursing
* Significant co-morbidity preventing study completion
* Terminal conditions with a life expectancy of less than two years
* Participation in another study that would confound the results of this study
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Optimize RV Team
Role: STUDY_CHAIR
Medtronic
Locations
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Bridgeport, Connecticut, United States
Clearwater, Florida, United States
Hudson, Florida, United States
Des Moines, Iowa, United States
Silver Spring, Maryland, United States
Takoma Park, Maryland, United States
Southfield, Michigan, United States
Saint Paul, Minnesota, United States
Omaha, Nebraska, United States
Cleveland, Ohio, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Tomball, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Montreal, , Canada
Hong Kong, , China
Ramat Gan, , Israel
Florence, , Italy
Rovigo, , Italy
Doha, , Qatar
Countries
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Other Identifiers
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604
Identifier Type: -
Identifier Source: org_study_id
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