Clinical trial NCT00748735: Left Ventricular Lead Position in Cardiac Resynchronization Therapy
Official title: Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy by Myocardial Deformation Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: cardiac resynchronization therapy
echocardiography
heart failure
left ventricular function
pacing
myocardial deformation imaging
Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2008-09-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in LV function and LV remodelling
timeFrame: 6 to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Cardiology, RWTH Aachen University Hospital
Study officials:
affiliation: RWTH Aachen University Hospital
name: Michael Becker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RWTH Aachen University Hospital
name: Rainer Hoffmann, MD
role: STUDY_CHAIR
References:
citation: Becker M, Franke A, Breithardt OA, Ocklenburg C, Kaminski T, Kramann R, Knackstedt C, Stellbrink C, Hanrath P, Schauerte P, Hoffmann R. Impact of left ventricular lead position on the efficacy of cardiac resynchronisation therapy: a two-dimensional strain echocardiography study. Heart. 2007 Oct;93(10):1197-203. doi: 10.1136/hrt.2006.095612. Epub 2007 Feb 19.
citation: Becker M, Kramann R, Franke A, Breithardt OA, Heussen N, Knackstedt C, Stellbrink C, Schauerte P, Kelm M, Hoffmann R. Impact of left ventricular lead position in cardiac resynchronization therapy on left ventricular remodelling. A circumferential strain analysis based on 2D echocardiography. Eur Heart J. 2007 May;28(10):1211-20. doi: 10.1093/eurheartj/ehm034. Epub 2007 Apr 10.
citation: Becker M, Altiok E, Ocklenburg C, Krings R, Adams D, Lysansky M, Vogel B, Schauerte P, Knackstedt C, Hoffmann R. Analysis of LV lead position in cardiac resynchronization therapy using different imaging modalities. JACC Cardiovasc Imaging. 2010 May;3(5):472-81. doi: 10.1016/j.jcmg.2009.11.016.