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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00825006

Enrollment

Registered

2009-01-19

Start date

2009-01-31

Completion date

2009-12-31

Last updated

2009-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiac resynchronization therapy, Anodal stimulation

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.

Interventions

DEVICETriple 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.

Study design

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Contacts

Primary ContactMichael Glikson, MD

mglikson@tau.ac.il+97235302604

Backup ContactAlon Barsheshet, MD

alonyaell@bezeqint.net+97235302604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026