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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00825006
Recruitment Status : Unknown
Verified January 2009 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : January 19, 2009
Last Update Posted : January 19, 2009
Information provided by:
Sheba Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Triple site pacing mode Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Anodal Stimulation on Left Ventricular Desynchrony and Hemodynamics in Patients With a Biventricular Pacemaker
Study Start Date : January 2009
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : December 2009

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 Name: anodal stimulation, triple site pacing

Primary Outcome Measures :
  1. Myocardial Performance Index, dP/dT [ Time Frame: After 10 minutes of triple site pacing and 10 minutes of dual sute pacing ]

Secondary Outcome Measures :
  1. Inter and intraventricular dyssynchrony parameters, LV volumes, LVEF [ Time Frame: After 10 minutes of triple site pacing and 10 minutes of dual site pacing ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00825006

Contact: Michael Glikson, MD +97235302604
Contact: Alon Barsheshet, MD +97235302604

Heart Institute, Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: Alon Barsheshet, MD    +97235302604   
Principal Investigator: Michael Glikson, MD         
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Michael Glikson, MD Heart Institute, Sheba Medical Center

Responsible Party: Dr Alon Barsheshet, Sheba Medical Center, Heart Institute Identifier: NCT00825006     History of Changes
Other Study ID Numbers: SHEBA-08-5076-MG-CTIL
First Posted: January 19, 2009    Key Record Dates
Last Update Posted: January 19, 2009
Last Verified: January 2009

Keywords provided by Sheba Medical Center:
Cardiac resynchronization therapy
Anodal stimulation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases