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| Name | Class |
|---|---|
| University of Chicago | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | guided implantation of the left ventricular lead |
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| 2 | Placebo Comparator | standard implantation of the left ventricular lead |
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| Pilot Group | Experimental | feasibility of guided placement of CRT-leads in 20 Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beutel TM | Device | application of BeutelTM |
| |
| standard |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of non-responders regarding ejection fraction | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Knackstedt, MD | RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine | Aachen | North Rhine-Westphalia | 52074 | Germany |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Other |
standard procedure will be applied but no Beutel TM software |
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| software Beutel TM | Device | application of BeutelTM to patients data for determination of site of latest contraction |
|