The Effects of Anodal Stimulation on Echocardiographic Outcome in Patients With Cardiac Resynchronization Therapy
Recruitment status was Recruiting
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.
|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|
- Myocardial Performance Index, dP/dT [ Time Frame: After 10 minutes of triple site pacing and 10 minutes of dual sute pacing ] [ Designated as safety issue: No ]
- Inter and intraventricular dyssynchrony parameters, LV volumes, LVEF [ Time Frame: After 10 minutes of triple site pacing and 10 minutes of dual site pacing ] [ Designated as safety issue: No ]
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825006
|Contact: Michael Glikson, MDfirstname.lastname@example.org|
|Contact: Alon Barsheshet, MDemail@example.com|
|Heart Institute, Sheba Medical Center||Recruiting|
|Tel Hashomer, Israel, 52621|
|Contact: Alon Barsheshet, MD +97235302604 firstname.lastname@example.org|
|Principal Investigator: Michael Glikson, MD|
|Principal Investigator:||Michael Glikson, MD||Heart Institute, Sheba Medical Center|