Left Ventricular Lead Position in Cardiac Resynchronization Therapy

September 8, 2008 updated by: RWTH Aachen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A1
heart failure patients undergoing CRT implantation
Procedure: Implantation of a cardiac resynchronization therapy device
Procedure: Echocardiography (myocardial deformation imaging)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in LV function and LV remodelling
Time Frame: 6 to 12 months
6 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 7, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (ESTIMATE)

September 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2008

Last Update Submitted That Met QC Criteria

September 8, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB-2008-CRT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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