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OpenTrials
Completed

NCT Number: NCT00764075

Guided Placement of CRT-Leads

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beutel TM

Device

application of BeutelTM

standard

Other

standard procedure will be applied but no Beutel TM software

software Beutel TM

Device

application of BeutelTM to patients data for determination of site of latest contraction

Primary outcomes

  1. Rate of non-responders regarding ejection fraction

    Time frame: 6 months

Secondary outcomes

  1. rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Collaborators

  • University of Chicago

Registry information

Official study title

CT and 3D-Echocardiography Placement of CRT-Leads

Acronym: EK138/08

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 1, 2008
Registry last updated
Jul 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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