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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Sheba Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Sheba Medical Center Identifier:
First received: March 9, 2008
Last updated: January 16, 2009
Last verified: January 2009
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 Intervention
Heart Failure Device: Triple site pacing mode

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Anodal Stimulation on Left Ventricular Desynchrony and Hemodynamics in Patients With a Biventricular Pacemaker

Further study details as provided by Sheba Medical Center:

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

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

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Dr Alon Barsheshet, Sheba Medical Center, Heart Institute Identifier: NCT00825006     History of Changes
Other Study ID Numbers: SHEBA-08-5076-MG-CTIL
Study First Received: March 9, 2008
Last Updated: January 16, 2009

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on July 19, 2017