Status:
COMPLETED
Guided Placement of CRT-Leads
Lead Sponsor:
RWTH Aachen University
Collaborating Sponsors:
University of Chicago
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this open, prospective, randomized, parallel group, German-American, two-center, Phase I study the standard-approach CRT-implantation will be compared to a guided CRT-implantation after determining...
Detailed Description
Patients will be allocated to two groups with either 1. Guided implantation of the left ventricular lead 2. Empirical implantation of the left ventricular lead (current clinical standard) For Treatm...
Eligibility Criteria
Inclusion
- Congestive heart failure,
- Ejection fraction \<35%,
- Complete left bundle branch block \>120ms,
- NYHA II,III or IV
Exclusion
- Patients not fulfilling the inclusion criteria or not capable/mental able to understand and follow the instructions;
- Impaired kidney function (GFR \<30ml/min;
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00764075
Start Date
October 1 2008
End Date
June 1 2011
Last Update
July 7 2011
Active Locations (1)
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1
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, North Rhine-Westphalia, Germany, 52074