Heart FailureNCT00825006
The Effects of Anodal Stimulation on Echocardiographic Outcome in Patients With Cardiac Resynchronization Therapy
A study testing Triple site pacing mode in people with Heart Failure, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Triple site pacing mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Heart Institute, Sheba Medical Center
Tel HaShomer, 52621
Alon Barsheshet, MD, +97235302604, alonyaell@bezeqint.net
Michael Glikson, MD
About this study
Official title: The Effects of Anodal Stimulation on Left Ventricular Desynchrony and Hemodynamics in Patients With a Biventricular Pacemaker
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Triple site pacing mode
- Keywords
- Cardiac resynchronization therapy, Anodal stimulation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple site pacing modeDevice
Also called anodal stimulation, triple site pacing
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Dual site pacing (LV tip electrode and RV tip electrode) |
| Triple site pacing | Experimental | Triple site pacing(LV tip electrode,RV tip electrode and RV ring electrode) Receives: Device: Triple site pacing mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Performance Index, dP/dT
Measured: 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
Measured: After 10 minutes of triple site pacing and 10 minutes of dual site pacing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Michael Glikson, MD, Principal investigator, Heart Institute, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825006
- Sponsor's protocol ID
- SHEBA-08-5076-MG-CTIL
- Status last verified
- Jan 2009
- First submitted
- 9 Mar 2008
- Last updated
- 19 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Anodal Stimulation on Left Ventricular Desynchrony and Hemodynamics in Patients With a Biventricular Pacemaker
- ClinicalTrials.gov ID
- NCT00825006
- Acronym / sponsor ID
- SHEBA-08-5076-MG-CTIL
- Conditions
- Heart Failure
- Keywords
- Cardiac resynchronization therapy, Anodal stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Dual site pacing (LV tip electrode and RV tip electrode) |
| Triple site pacing | Experimental | Device: Triple site pacing modeTriple site pacing(LV tip electrode,RV tip electrode and RV ring electrode) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple site pacing modeAlso: anodal stimulation, triple site pacingThe 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. | Device | Triple site pacing |
Primary outcome
Myocardial Performance Index, dP/dT
Time frame: After 10 minutes of triple site pacing and 10 minutes of dual sute pacing
1 secondary outcome
Inter and intraventricular dyssynchrony parameters, LV volumes, LVEF
Time frame: After 10 minutes of triple site pacing and 10 minutes of dual site pacing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Glikson, MD principal investigator
Heart Institute, Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple site pacing mode in people with Heart Failure, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Glikson, MD (+97235302604, mglikson@tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Performance Index, dP/dT (time frame: After 10 minutes of triple site pacing and 10 minutes of dual sute pacing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2009; AzTrials last refreshed its copy on 8 Nov 2026.