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Guided Placement of CRT-Leads (EK138/08)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00764075
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : July 7, 2011
University of Chicago
Information provided by:
RWTH Aachen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Beutel TM Other: standard Device: software Beutel TM Not Applicable

Detailed Description:

Patients will be allocated to two groups with either

  1. Guided implantation of the left ventricular lead
  2. 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:

  1. Technical success in placing the electrode in the target vessel.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CT and 3D-Echocardiography Placement of CRT-Leads
Study Start Date : October 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 1
guided implantation of the left ventricular lead
Device: Beutel TM
application of BeutelTM

Placebo Comparator: 2
standard implantation of the left ventricular lead
Other: standard
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

Primary Outcome Measures :
  1. Rate of non-responders regarding ejection fraction [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Congestive heart failure,
  • Ejection fraction <35%,
  • Complete left bundle branch block >120ms,

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00764075

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Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
University of Chicago
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Principal Investigator: Christian Knackstedt, MD RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
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Responsible Party: Christian Knackstedt, MD, RWTH Aachen University Identifier: NCT00764075    
Other Study ID Numbers: CRT-Study
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011
Keywords provided by RWTH Aachen University:
heart failure; EF<35%; NYHA II, III or IV
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases