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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Sheba Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT00825006

First received: March 9, 2008

Last updated: January 16, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 9, 2008

Last Updated Date

January 16, 2009

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00825006 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

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

Study Arm (s)

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)

Intervention: Device: Triple site pacing mode

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Michael Glikson, MD	+97235302604	mglikson@tau.ac.il
Contact: Alon Barsheshet, MD	+97235302604	alonyaell@bezeqint.net

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00825006

Other Study ID Numbers ^ICMJE

SHEBA-08-5076-MG-CTIL

Has Data Monitoring Committee

Responsible Party

Dr Alon Barsheshet, Sheba Medical Center, Heart Institute

Study Sponsor ^ICMJE

Sheba Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael Glikson, MD

Heart Institute, Sheba Medical Center

Information Provided By

Sheba Medical Center

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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