Status:
COMPLETED
Optimize RV Follow-up Selective Site Pacing Clinical Trial
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Cardiac Pacing
Right Ventricular Pacing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the Optimize RV Follow-Up 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 ...
Detailed Description
The Optimize RV Follow-Up Selective Site Pacing Clinical Trial is open to subjects that were previously enrolled in the Optimize RV Selective Site Pacing Clinical Trial.
Eligibility Criteria
Inclusion
- Subjects enrolled in the Optimize RV study (version 3, dated 6 March 2007)
- Subjects or legal guardians who are willing and able to sign an Informed Consent (and Authorization to use and Disclose Health Information Form, if applicable)
Exclusion
- Subjects who have a device that was programmed outside the Optimize RV programming requirements
- Subjects implanted with and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
- Subjects who are pregnant or nursing
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00949715
Start Date
September 1 2009
End Date
December 1 2011
Last Update
February 15 2018
Active Locations (12)
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1
Des Moines, Iowa, United States
2
Silver Spring, Maryland, United States
3
Southfield, Michigan, United States
4
Saint Paul, Minnesota, United States