Left Ventricular Lead Position in Cardiac Resynchronization Therapy - Full Text View

Purpose

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.

Condition	Intervention
Heart Failure	Procedure: Implantation of a cardiac resynchronization therapy device Procedure: Echocardiography (myocardial deformation imaging)

Study Type:	Observational
Study Design:	Time Perspective: Retrospective
Official Title:	Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy by Myocardial Deformation Imaging

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:

Improvement in LV function and LV remodelling [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]

Enrollment:

55

Groups/Cohorts	Assigned Interventions
A1 heart failure patients undergoing CRT implantation	Procedure: Implantation of a cardiac resynchronization therapy device Procedure: Echocardiography (myocardial deformation imaging)

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748735

Locations

Germany
Department of Cardiology, RWTH Aachen University Hospital
Aachen, Germany, 52057

Sponsors and Collaborators

RWTH Aachen University

Investigators

Principal Investigator:	Michael Becker, MD	RWTH Aachen University Hospital
Study Chair:	Rainer Hoffmann, MD	RWTH Aachen University Hospital

More Information

Publications:

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. Epub 2007 Feb 19.

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. Epub 2007 Apr 10.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00748735 History of Changes
Other Study ID Numbers:	MB-2008-CRT
Study First Received:	September 7, 2008
Last Updated:	September 8, 2008
Health Authority:	Germany: Ethics Commission

Keywords provided by RWTH Aachen University:

cardiac resynchronization therapy
echocardiography
heart failure
left ventricular function

pacing
myocardial deformation imaging
Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013