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

S

Sheba Medical Center

Status

Unknown

Conditions

Heart Failure

Treatments

Device: Triple site pacing mode

Study type

Interventional

Funder types

Other

Identifiers

NCT00825006
SHEBA-08-5076-MG-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Control
No Intervention group
Description:
Dual site pacing (LV tip electrode and RV tip electrode)
Triple site pacing
Experimental group
Description:
Triple site pacing(LV tip electrode,RV tip electrode and RV ring electrode)
Treatment:
Device: Triple site pacing mode

Trial contacts and locations

1

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Central trial contact

Alon Barsheshet, MD; Michael Glikson, MD

Data sourced from clinicaltrials.gov

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