Left Ventricular Lead Position in Cardiac Resynchronization Therapy

Heart Failure Clinical Trial

Official title:

Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy by Myocardial Deformation Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748735
• Other study ID #: MB-2008-CRT
• Status: Completed
• Phase: N/A
• First received: September 7, 2008
• Last updated: September 8, 2008

Study information

• Verified date: January 2008
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Implantation of a cardiac resynchronization therapy device

• Echocardiography (myocardial deformation imaging)

Locations

Country	Name	City	State
Germany	Department of Cardiology, RWTH Aachen University Hospital	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. Epub 2007 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in LV function and LV remodelling		6 to 12 months	No