Left Ventricular Lead Position in Cardiac Resynchronization Therapy

NCT00748735 | Completed

• 1 other identifier: MB-2008-CRT
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Improvement in LV function and LV remodelling

  6 to 12 months

Study Arms (1)

A1

heart failure patients undergoing CRT implantation

Procedure: Implantation of a cardiac resynchronization therapy device; Procedure: Echocardiography (myocardial deformation imaging)

Interventions

Implantation of a cardiac resynchronization therapy device PROCEDURE

A1

Echocardiography (myocardial deformation imaging) PROCEDURE

A1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Department of Cardiology, RWTH Aachen University Hospital

Aachen, 52057, Germany

Location

Related Publications (3)

• 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.

  PMID: 17309913 BACKGROUND

• 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.

  PMID: 17426079 BACKGROUND

• 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.

  PMID: 20466342 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael Becker, MD

  RWTH Aachen University Hospital

  PRINCIPAL INVESTIGATOR

• Rainer Hoffmann, MD

  RWTH Aachen University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2008
• First Posted: September 9, 2008
• Last Updated: September 9, 2008

Record last verified: 2008-01

Locations

DE (1)