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
  Purpose

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.


Condition Intervention
Heart Failure
Device: Triple site pacing mode

Study Type: Interventional
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

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825006

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

Locations
Israel
Heart Institute, Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: Alon Barsheshet, MD    +97235302604    alonyaell@bezeqint.net   
Principal Investigator: Michael Glikson, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Michael Glikson, MD Heart Institute, Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr Alon Barsheshet, Sheba Medical Center, Heart Institute
ClinicalTrials.gov Identifier: NCT00825006     History of Changes
Other Study ID Numbers: SHEBA-08-5076-MG-CTIL
Study First Received: March 9, 2008
Last Updated: January 16, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Cardiac resynchronization therapy
Anodal stimulation

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014