Status:
COMPLETED
Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
Lead Sponsor:
Guidant Corporation
Conditions:
Bradycardia
Heart Block
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated. I...
Eligibility Criteria
Inclusion
- Age \< 18 years, indication for pacemaker implantation according to current guidelines, written consent of the patient
Exclusion
- Live expectancy \< 6 months, pregnancy or women without contraception in birth bearing age, inability or refusal to sign consent form, simultaneous participation in another clinical trial, contraindication for any procedure required during pacemaker implantation, patients who need other pacemaker systems including pacing leads than those required by the protocol, heart failure (LVEF \<35%, QRS-Width\>150ms), functional (rate dependent) bundle branch bloc
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00180557
Start Date
September 1 2003
End Date
May 1 2007
Last Update
March 17 2015
Active Locations (1)
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1
Krankenhaus der barmherzigen Schwestern
Ried im Innkreis, Austria