Left Ventricular Lead Position in Cardiac Resynchronization Therapy

This study has been completed.
Sponsor:
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00748735
First received: September 7, 2008
Last updated: September 8, 2008
Last verified: January 2008

September 7, 2008
September 8, 2008
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Improvement in LV function and LV remodelling [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00748735 on ClinicalTrials.gov Archive Site
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Left Ventricular Lead Position in Cardiac Resynchronization Therapy
Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy by Myocardial Deformation Imaging

Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for optimal definition of LV lead position.

In a 16 segment model circumferential strain will be used to determine the segment with latest peak systolic circumferential strain prior to CRT, considered as the optimal LV lead target. LV lead will be defined by (1) fluoroscopy, (2) the maximal temporal difference of peak circumferential strain before-to-on CRT and (3) the earliest peak systolic circumferential strain during LV pacing. For all 3 modalities optimal LV lead position is defined as concordance or immediate neighbouring of the segment with defined LV lead position to the determined optimal target segment. At follow-up echocardiography will be performed to determine improvement in LV function and remodeling.

Observational
Time Perspective: Retrospective
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Probability Sample

Consecutive patients with end-stage heart failure and sinus rhythm, scheduled for new implantation of a biventricular pacemaker were included in the study. Criteria for CRT implantation were New York Heart Association (NYHA) functional class III (N=35) or IV (N=21) despite optimal pharmacologic therapy and evidence of LV systolic dysfunction with ejection fraction <35% and a QRS >120ms.

Heart Failure
  • Procedure: Implantation of a cardiac resynchronization therapy device
  • Procedure: Echocardiography (myocardial deformation imaging)
A1
heart failure patients undergoing CRT implantation
Interventions:
  • Procedure: Implantation of a cardiac resynchronization therapy device
  • Procedure: Echocardiography (myocardial deformation imaging)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
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Inclusion Criteria:

  • See above
  • Males and females
  • Ages 18 to 80 years

Exclusion Criteria:

  • Patients who already have had a pacemaker device
  • Patients with poor echocardiographic window
  • Patients who are not able to understand the study and to give informed written consent
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00748735
MB-2008-CRT
No
Not Provided
RWTH Aachen University
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Principal Investigator: Michael Becker, MD RWTH Aachen University Hospital
Study Chair: Rainer Hoffmann, MD RWTH Aachen University Hospital
RWTH Aachen University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP