Guided Placement of CRT-Leads

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CT and 3D-Echocardiography Placement of CRT-Leads

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Beutel TM
* Other: standard
* Device: software Beutel TM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Congestive heart failure, Ejection fraction <35%, Complete left bundle branch block >120ms, NYHA II,III or IV Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>guided implantation of the left ventricular lead | Device: Beutel TM<br>* application of BeutelTM<br>|
| Placebo Comparator: 2<br>standard implantation of the left ventricular lead | Other: standard<br>* standard procedure will be applied but no Beutel TM software<br>|
| Experimental: Pilot Group<br>feasibility of guided placement of CRT-leads in 20 Patients | Device: software Beutel TM<br>* application of BeutelTM to patients data for determination of site of latest contraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of non-responders regarding ejection fraction |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure; EF<35%; NYHA II, III or IV