Guided Placement of CRT-Leads (EK138/08)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CT and 3D-Echocardiography Placement of CRT-Leads|
- Rate of non-responders regarding ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
guided implantation of the left ventricular lead
Device: Beutel TM
application of BeutelTM
Placebo Comparator: 2
standard implantation of the left ventricular lead
standard procedure will be applied but no Beutel TM software
Experimental: Pilot Group
feasibility of guided placement of CRT-leads in 20 Patients
Device: software Beutel TM
application of BeutelTM to patients data for determination of site of latest contraction
Patients will be allocated to two groups with either
- Guided implantation of the left ventricular lead
- 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:
- Technical success in placing the electrode in the target vessel.
- 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.
|Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine|
|Aachen, NRW, Germany, 52074|
|Principal Investigator:||Christian Knackstedt, MD||RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine|