Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2008-10-31
2011-06-30
Brief Summary
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Detailed Description
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1. Guided implantation of the left ventricular lead
2. Empirical implantation of the left ventricular lead (current clinical standard)
For Treatment Group a) the target vessel, which is the vessel with smallest distance between RLC and CVS is determined in advance and provided to the implanting physician. In case, this vessel is not amenable for lead positioning, a second vessel which is the second closest to the RLC is defined.
For Treatment Group b), the physician has to choose the vessel where to place the electrode without knowing the exact spatial orientation between that particular side-branch and the RLC.
In all patients, standard biventricular devices and leads are to be used. Aspects that are evaluated are:
1. Technical success in placing the electrode in the target vessel.
2. Failure due to dislocation during the implantation procedure or phrenic nerve stimulation.
Also, procedure duration, radiation exposure, and complications occurring during the procedure as well as post- operatively will be documented.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
guided implantation of the left ventricular lead
Beutel TM
application of BeutelTM
2
standard implantation of the left ventricular lead
standard
standard procedure will be applied but no Beutel TM software
Pilot Group
feasibility of guided placement of CRT-leads in 20 Patients
software Beutel TM
application of BeutelTM to patients data for determination of site of latest contraction
Interventions
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Beutel TM
application of BeutelTM
standard
standard procedure will be applied but no Beutel TM software
software Beutel TM
application of BeutelTM to patients data for determination of site of latest contraction
Eligibility Criteria
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Inclusion Criteria
* Ejection fraction \<35%,
* Complete left bundle branch block \>120ms,
* NYHA II,III or IV
* Impaired kidney function (GFR \<30ml/min;
* Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
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University of Chicago
OTHER
RWTH Aachen University
OTHER
Responsible Party
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RWTH Aachen University
Principal Investigators
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Christian Knackstedt, MD
Role: PRINCIPAL_INVESTIGATOR
RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
Locations
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Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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CRT-Study
Identifier Type: -
Identifier Source: org_study_id
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