Left Ventricular Lead Position in Cardiac Resynchronization Therapy

This study has been completed.
Sponsor:
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00748735
First received: September 7, 2008
Last updated: September 8, 2008
Last verified: January 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 18, 2014