Status:
SUSPENDED
SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes
Lead Sponsor:
Guidant Corporation
Conditions:
Bradycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism
Detailed Description
This investigation will study and compare 3 types of electrically identical, commercially available FineLine II Sterox leads with different fixation mechanisms. This trial has been designed to primari...
Eligibility Criteria
Inclusion
- Patients selected for participation in this investigation should be candidates for permanent pacemaker implantation chosen from the investigator's general patient population without regard for race or sex. Furthermore, these patients should, in the physician's general opinion, benefit from permanent pacemaker implantation with one of the study leads. Patients should be geographically stable and available for routine follow-up visits throughout the duration of the study. Patients must also be able and willing to provide informed consent.
Exclusion
- Patients who previously went through heart surgery should be excluded from the study.
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT00180570
Start Date
January 1 1997
End Date
January 1 2006
Last Update
March 11 2015
Active Locations (1)
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1
Sahlgrenska Sjukhuset i Göteborg Sweden,
Gothenburg, Sweden