Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, North Rhine-Westphalia, 52074, Germany
NCT Number: NCT00764075
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 the site of latest contraction and placement of the electrode as close as possible to this site, using a 5-step-scheme of imaging methods determining the site of latest contraction prior to implantation.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Aachen, North Rhine-Westphalia, 52074, Germany
Patients will be allocated to two groups with either
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:
Also, procedure duration, radiation exposure, and complications occurring during the procedure as well as post- operatively will be documented.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
application of BeutelTM
standard procedure will be applied but no Beutel TM software
application of BeutelTM to patients data for determination of site of latest contraction
Time frame: 6 months
Time frame: 6 months
RWTH Aachen University
Other
CT and 3D-Echocardiography Placement of CRT-Leads
Acronym: EK138/08
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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