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Left Ventricular Lead Position in Cardiac Resynchronization Therapy

NCT ID: NCT00748735

Last Updated: 2008-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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

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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.

Conditions

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Heart Failure

Keywords

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cardiac resynchronization therapy echocardiography heart failure left ventricular function pacing myocardial deformation imaging Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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A1

heart failure patients undergoing CRT implantation

Implantation of a cardiac resynchronization therapy device

Intervention Type PROCEDURE

Echocardiography (myocardial deformation imaging)

Intervention Type PROCEDURE

Interventions

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Implantation of a cardiac resynchronization therapy device

Intervention Type PROCEDURE

Echocardiography (myocardial deformation imaging)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Principal Investigators

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Michael Becker, MD

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University Hospital

Rainer Hoffmann, MD

Role: STUDY_CHAIR

RWTH Aachen University Hospital

Locations

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Department of Cardiology, RWTH Aachen University Hospital

Aachen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 17309913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17426079 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20466342 (View on PubMed)

Other Identifiers

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MB-2008-CRT

Identifier Type: -

Identifier Source: org_study_id