Guided Placement of CRT-Leads (EK138/08)

This study has been completed.
Sponsor:
Collaborator:
University of Chicago
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00764075
First received: September 26, 2008
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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 Intervention
Heart Failure
Device: Beutel TM
Other: standard
Device: software Beutel TM

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Rate of non-responders regarding ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764075

Locations
Germany
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
University of Chicago
Investigators
Principal Investigator: Christian Knackstedt, MD RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
  More Information

No publications provided

Responsible Party: Christian Knackstedt, MD, RWTH Aachen University
ClinicalTrials.gov Identifier: NCT00764075     History of Changes
Other Study ID Numbers: CRT-Study
Study First Received: September 26, 2008
Last Updated: July 6, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by RWTH Aachen University:
heart failure; EF<35%; NYHA II, III or IV

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014