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

Not Applicable

• Conditions: Heart Failure
• Interventions: Device: Triple site pacing mode

• Registration Number: NCT00825006
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2008-03-09
• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted QC: 2009-01-16
• Last Update Submitted: 2009-01-16
• Study First Posted: 2009-01-19
• Last Update Posted: 2009-01-19
• Primary Completion: 2009-07
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Triple site pacing	Triple site pacing mode	Triple site pacing(LV tip electrode,RV tip electrode and RV ring electrode)

Primary Outcome Measures

Name	Time	Method
Myocardial Performance Index, dP/dT	After 10 minutes of triple site pacing and 10 minutes of dual sute pacing

Secondary Outcome Measures

Name	Time	Method
Inter and intraventricular dyssynchrony parameters, LV volumes, LVEF	After 10 minutes of triple site pacing and 10 minutes of dual site pacing

Trial Locations

Locations (1)

Heart Institute, Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel