An interventional study of Beutel TM and standard in Heart Failure, sponsored by RWTH Aachen University. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-07.
Sponsored by RWTH Aachen University · Not applicable, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 132 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
guided implantation of the left ventricular lead
Device: Beutel TM
standard implantation of the left ventricular lead
Other: standard
feasibility of guided placement of CRT-leads in 20 Patients
Device: software Beutel TM
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
Rate of non-responders regarding ejection fraction
Time frame: 6 months
rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume
Time frame: 6 months
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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RWTH Aachen University