The Effects of Anodal Stimulation on Echocardiographic Outcome in Patients With Cardiac Resynchronization Therapy

January 16, 2009 updated by: Sheba Medical Center

The Effects of Anodal Stimulation on Left Ventricular Desynchrony and Hemodynamics in Patients With a Biventricular Pacemaker

To investigate the hemodynamic, inter and intraventricular desynchrony effects of anodal stimulation and triple site pacing compared with the usual dual site pacing by echocardiography and Tissue Doppler Imaging.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Thirty patients who underwent CRT and had evidence of anodal stimulation will be included in the study. All patients undergo a conventional echocardiography after 10 minutes of continuous triple site pacing and after 10 minutes of continuous dual site pacing (Customary biventricular pacing).Echocardiography studies will be performed to measure dP/dT using continuous flow Doppler velocity profiles of mitral regurgitation, LV volumes and Left ventricular ejection fraction. Left intraventricular desynchrony is assessed by using TDI.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

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

  • Israel
      • Tel Hashomer, Israel, 52621
        • Recruiting
        • Heart Institute, Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Glikson, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with biventricular pacemakers who met currently accepted indications for CRT, including dilated cardiomyopathy with LV ejection fraction < 35% (ischemic and nonischemic etiologies) with New York Heart Association class III to IV congestive heart failure and QRS duration > 120 ms.

Exclusion Criteria:

  • Patients with first generation CRT device
  • Integrated bipolar defibrillator device
  • Atrial fibrillation during the screening phase
  • Patients who cannot tolerate triple site pacing for several minutes (i.e diaphragmatic pacing)
  • Patients with epicardial LV leads
  • Patients with LV leads located out of the lateral or posterolateral areas

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

  • Primary Purpose: Treatment
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Dual site pacing (LV tip electrode and RV tip electrode)
Experimental: Triple site pacing
Triple site pacing(LV tip electrode,RV tip electrode and RV ring electrode)
Device: Triple site pacing mode

The experimental "Triple site pacing mode" includes pacing with Cardiac resynchronization therapy device using two leads; one in the right ventricle (RV) and one in the left ventricle (LV) but stimulates three sites: LV tip, RV tip and RV ring (instead of the usual two sites: LV tip and RV ring.

Patients with evidence of improved LV dyssinchrony parameters during the triple pacing mode (anodal stimulation) will be programmed to anodal stimulation for 3 months.

Other Names:
  • anodal stimulation, triple site pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myocardial Performance Index, dP/dT
Time Frame: After 10 minutes of triple site pacing and 10 minutes of dual sute pacing
After 10 minutes of triple site pacing and 10 minutes of dual sute pacing

Secondary Outcome Measures

Outcome Measure
Time Frame
Inter and intraventricular dyssynchrony parameters, LV volumes, LVEF
Time Frame: After 10 minutes of triple site pacing and 10 minutes of dual site pacing
After 10 minutes of triple site pacing and 10 minutes of dual site pacing

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Michael Glikson, MD, Heart Institute, Sheba Medical Center

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 Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

July 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

March 9, 2008

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 19, 2009

Study Record Updates

Last Update Posted (Estimate)

January 19, 2009

Last Update Submitted That Met QC Criteria

January 16, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-08-5076-MG-CTIL

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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