Status:
TERMINATED
Optimize RV Selective Site Pacing Clinical Trial
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Cardiac Pacing, Artificial
Cardiac Pacemaker, Artificial
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the Optimize RV study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of se...
Eligibility Criteria
Inclusion
- Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time
- 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
- Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines)
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00422669
Start Date
January 1 2007
End Date
May 1 2009
Last Update
January 31 2013
Active Locations (22)
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1
Bridgeport, Connecticut, United States
2
Clearwater, Florida, United States
3
Hudson, Florida, United States
4
Des Moines, Iowa, United States