The Effects of Anodal Stimulation on Echocardiographic Outcome in Patients With Cardiac Resynchronization Therapy
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Jan 2009
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedFirst Posted
Study publicly available on registry
January 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJanuary 19, 2009
January 1, 2009
6 months
March 9, 2008
January 16, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial Performance Index, dP/dT
After 10 minutes of triple site pacing and 10 minutes of dual sute pacing
Secondary Outcomes (1)
Inter and intraventricular dyssynchrony parameters, LV volumes, LVEF
After 10 minutes of triple site pacing and 10 minutes of dual site pacing
Study Arms (2)
Control
NO INTERVENTIONDual site pacing (LV tip electrode and RV tip electrode)
Triple site pacing
EXPERIMENTALTriple site pacing(LV tip electrode,RV tip electrode and RV ring electrode)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart Institute, Sheba Medical Center
Tel Litwinsky, 52621, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Glikson, MD
Heart Institute, Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 9, 2008
First Posted
January 19, 2009
Study Start
January 1, 2009
Primary Completion
July 1, 2009
Study Completion
December 1, 2009
Last Updated
January 19, 2009
Record last verified: 2009-01