Back to resultsThe Effects of Anodal Stimulation on Echocardiographic Outcome in Patients With Cardiac Resynchronization Therapy
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Triple site pacing mode
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Cardiac resynchronization therapy, Anodal stimulation
Eligibility 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
Sites / Locations
- Heart Institute, Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Triple site pacing
Arm Description
Dual site pacing (LV tip electrode and RV tip electrode)
Triple site pacing(LV tip electrode,RV tip electrode and RV ring electrode)
Outcomes
Primary Outcome Measures
Myocardial Performance Index, dP/dT
Secondary Outcome Measures
Inter and intraventricular dyssynchrony parameters, LV volumes, LVEF
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00825006
Brief Title
The Effects of Anodal Stimulation on Echocardiographic Outcome in Patients With Cardiac Resynchronization Therapy
Official Title
The Effects of Anodal Stimulation on Left Ventricular Desynchrony and Hemodynamics in Patients With a Biventricular Pacemaker
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac resynchronization therapy, Anodal stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Dual site pacing (LV tip electrode and RV tip electrode)
Arm Title
Triple site pacing
Arm Type
Experimental
Arm Description
Triple site pacing(LV tip electrode,RV tip electrode and RV ring electrode)
Intervention Type
Device
Intervention Name(s)
Triple site pacing mode
Other Intervention Name(s)
anodal stimulation, triple site pacing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Myocardial Performance Index, dP/dT
Time Frame
After 10 minutes of triple site pacing and 10 minutes of dual sute pacing
Secondary Outcome Measure Information:
Title
Inter and intraventricular dyssynchrony parameters, LV volumes, LVEF
Time Frame
After 10 minutes of triple site pacing and 10 minutes of dual site pacing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Glikson, MD
Phone
+97235302604
Email
mglikson@tau.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Barsheshet, MD
Phone
+97235302604
Email
alonyaell@bezeqint.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Glikson, MD
Organizational Affiliation
Heart Institute, Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute, Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alon Barsheshet, MD
Phone
+97235302604
Email
alonyaell@bezeqint.net
First Name & Middle Initial & Last Name & Degree
Michael Glikson, MD
12. IPD Sharing Statement
Learn more about this trial
The Effects of Anodal Stimulation on Echocardiographic Outcome in Patients With Cardiac Resynchronization Therapy
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