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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00825006
• Other study ID #: SHEBA-08-5076-MG-CTIL
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2008
• Last updated: January 16, 2009
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: Sheba Medical Center
• Contact: Michael Glikson, MD
• Phone: +97235302604
• Email: mglikson[@]tau.ac.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Israel	Heart Institute, Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Performance Index, dP/dT		After 10 minutes of triple site pacing and 10 minutes of dual sute pacing	No
Secondary	Inter and intraventricular dyssynchrony parameters, LV volumes, LVEF		After 10 minutes of triple site pacing and 10 minutes of dual site pacing	No