The EASYTRAK EPI Clinical Investigation (EASYTRAK EPI)
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|ClinicalTrials.gov Identifier: NCT00158925|
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : April 28, 2017
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bradycardia Congestive Heart Failure||Device: EASYTRAK EPI lead||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The EASYTRAK EPI Clinical Investigation|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
Experimental: EASYTRAK EPI Lead
Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.
Device: EASYTRAK EPI lead
EASYTRAK EPI lead
- Chronic Pacing Thresholds at 3 Months [ Time Frame: 3 months ]The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.
- Chronic Pacing Impedances at 3 Months [ Time Frame: 3 months ]The expected mean impedance is 500 Ohms.
- Chronic Sensing Amplitudes at 3 Months [ Time Frame: 3 months ]The expected mean is 10mV.
- Lead-related Complication-free Rate at 3 Months [ Time Frame: 3 months ]The estimated target value for this endpoint is 80%.
- Lead Implant Time [ Time Frame: Implant ]The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158925
|United States, Minnesota|
|Multiple Locations in the US|
|Saint Paul, Minnesota, United States, 55112|
|Principal Investigator:||Daniel Beckman, MD||The Methodist Hospital System|