Ventricular TachycardiaNCT01966016
Efficacy and Safety of Multisite Cardiac Resynchronization Therapy
A study testing Pacing in people with Ventricular Tachycardia, run by Barzilai Medical Center at 1 site in Israel.
Trial summary
Cardiac resynchronization therapy (CRT) is a proven therapy in patients with severe left ventricular (LV) dysfunction with ejection fraction (EF)<35%., moderate to severe congestive heart failure and wide QRS in ECG. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Nov 2012to 17 Nov 2015
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe LV dysfunction, severe heart failure (NYHA FC III-IV and at least one hospitalization for congestive heart failure in the past 3 months before inclusion) on optimal medical treatment and that have narrow complex QRS or RBBB. These patients have an indication for ICD implantation.
- Patients with conventional indications for CRTD implantation and EF<25%, QRS>150ms and severe heart failure (NYHA FC>III).
- Patients with an indication for pacemaker implantation and an expected high rate of pacing (complete AV block or prior to AVN ablation) and a wish to avoid RV pacing (example: severe TR).
- Patients with refractory ventricular tachycardia and severe LV dysfunction (EF<35%) that continue to have VT episodes despite antiarrhythmic drugs and despite recurrent VT ablations. Those patients have indication for ICD.
- Patients with conventional indications for CRT but during implantation the anatomy is such that the site of implantation is not optimal (QRS>200ms). In these cases we will add an electrode in the opposite branch of the coronary sinus.
Who cannot join
- Pregnancy
- Patients included in another study
- Patients that have other solutions that could avoid implantation (medications, ablation, etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Multisite Cardiac Resynchronization Therapy - a Prospective Single Center Study in Selected Patient Population
Cardiac resynchronization therapy (CRT) is a proven therapy in patients with severe left ventricular (LV) dysfunction with ejection fraction (EF)<35%., moderate to severe congestive heart failure and wide QRS in ECG. Positive response presents as improvement in quality of life, decrease in congestive hrat failure symptoms and signs, improvements in echocardiographic measurements and longer survival. About 30% of the patients do not respond to this treatment.
A decrease in clinical response to CRT is expected in patients with those predictors: advanced age, male, ischemic etiology of cardiomyopathy, Non-LBBB pattern in ECG, lack of mechanical dyssynchrony, large scar in LV, congestive heart failure stage IV, and non-cardiac co-morbidities (lung disease, pulmonary hypertension, renal failure and diabetes).
Read more
There are few solutions to increase the rate of clinical response to CRT, for example: endocardial pacing of LV or pacing a few simultaneous sites on LV. A study that investigated a method of simultaneous pacing on LV of patients with congestive heart failure and LBBB with QRS>150ms has shown major improvement of cardiac contraction (increased dP/dtmax) compared to a single pacing site over a postero-basal or lateral wall site).
Implantation of pacemaker leads- one in right ventricle (RV) and two over LV, i.e. multisite cardiac resynchronization therapy (MSCRT), has a few potential advantages, compared to conventional CRT.
- Conditions
- Ventricular Tachycardia
- Being tested
- Pacing
- Keywords
- LV- Left Ventricular, CRT- Cardiac resynchronization therapy, MSCRT- Multisite Cardiac resynchronization therapy (P-pacemaker; D-defibrillator), BBB -bundle branch block
- Medical subject headings
- Tachycardia, Ventricular, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacingProcedure or surgery
In this study we intend to include patients that have indication to and are intended to undergo CRT implantation with an additional electrode on LV, that have inclusion criteria and have signed an informed consent.
In this study we will include 20 patients for each study arm (overall 100)- each patient will have both treatment configurations and these two will be compared
| Study group | Role | What they receive |
|---|---|---|
| biventricular pacing | Experimental | The first configuration will be biventricular pacing (RV and postero-lateral branch of CS for LV pacing), as accepted Receives: Procedure: Pacing |
| triventricular pacing | Experimental | The second configuration will be triventricular pacing (RV+ postero-lateral branch of CS for LV pacing+ antero-lateral branch of CS for LV pacing) i.e. multisite LV pacing Receives: Procedure: Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multisite cardiac resynchronization therapy
In this research we intend to check the efficacy of MSCRT pacing mode in different populations of patients that are not yet included in the published guidelines.
Primary end point: Immediate improvement in echo measurements of LVESV of the patient (Each patient is his own control. We expect 15% improvement versus baseline echo measurements or a difference of 5% from one measurements to another).
Measured: 2 years
Secondary outcomes (1)
decrease in arrhythmia burden
A clinical improvement regarding: decrease in arrhythmia burden, improvement in 6 minute walk results, decrease in number of hospitalizations, improvement in NYHA FC of at least one grade, and improvement in quality of life scores.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study start20 Nov 2012
- Primary completion17 Nov 2015
- Study completion17 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arie Budovsky, Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966016
- Sponsor's protocol ID
- BRZ0046-12CTIL
- Status last verified
- Jan 2019
- First submitted
- 26 Aug 2013
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Multisite Cardiac Resynchronization Therapy - a Prospective Single Center Study in Selected Patient Population
- ClinicalTrials.gov ID
- NCT01966016
- Acronym / sponsor ID
- BRZ0046-12CTIL
- Conditions
- Ventricular Tachycardia
- Keywords
- LV- Left Ventricular, CRT- Cardiac resynchronization therapy, MSCRT- Multisite Cardiac resynchronization therapy (P-pacemaker; D-defibrillator), BBB -bundle branch block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- 20 Nov 2012 (actual)
- Primary completion
- 17 Nov 2015 (actual)
- Study completion
- 17 Nov 2015 (actual)
- First posted
- 21 Oct 2013 (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.
Cardiac resynchronization therapy (CRT) is a proven therapy in patients with severe left ventricular (LV) dysfunction with ejection fraction (EF)<35%., moderate to severe congestive heart failure and wide QRS in ECG. Positive response presents as improvement in quality of life, decrease in congestive hrat failure symptoms and signs, improvements in echocardiographic measurements and longer survival. About 30% of the patients do not respond to this treatment.
A decrease in clinical response to CRT is expected in patients with those predictors: advanced age, male, ischemic etiology of cardiomyopathy, Non-LBBB pattern in ECG, lack of mechanical dyssynchrony, large scar in LV, congestive heart failure stage IV, and non-cardiac co-morbidities (lung disease, pulmonary hypertension, renal failure and diabetes).
There are few solutions to increase the rate of clinical response to CRT, for example: endocardial pacing of LV or pacing a few simultaneous sites on LV. A study that investigated a method of simultaneous pacing on LV of patients with congestive heart failure and LBBB with QRS>150ms has shown major improvement of cardiac contraction (increased dP/dtmax) compared to a single pacing site over a postero-basal or lateral wall site).
Implantation of pacemaker leads- one in right ventricle (RV) and two over LV, i.e. multisite cardiac resynchronization therapy (MSCRT), has a few potential advantages, compared to conventional CRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biventricular pacing | Experimental | Procedure: PacingThe first configuration will be biventricular pacing (RV and postero-lateral branch of CS for LV pacing), as accepted |
| triventricular pacing | Experimental | Procedure: PacingThe second configuration will be triventricular pacing (RV+ postero-lateral branch of CS for LV pacing+ antero-lateral branch of CS for LV pacing) i.e. multisite LV pacing |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with severe LV dysfunction, severe heart failure (NYHA FC III-IV and at least one hospitalization for congestive heart failure in the past 3 months before inclusion) on optimal medical treatment and that have narrow complex QRS or RBBB. These patients have an indication for ICD implantation.
- Patients with conventional indications for CRTD implantation and EF<25%, QRS>150ms and severe heart failure (NYHA FC>III).
- Patients with an indication for pacemaker implantation and an expected high rate of pacing (complete AV block or prior to AVN ablation) and a wish to avoid RV pacing (example: severe TR).
- Patients with refractory ventricular tachycardia and severe LV dysfunction (EF<35%) that continue to have VT episodes despite antiarrhythmic drugs and despite recurrent VT ablations. Those patients have indication for ICD.
- Patients with conventional indications for CRT but during implantation the anatomy is such that the site of implantation is not optimal (QRS>200ms). In these cases we will add an electrode in the opposite branch of the coronary sinus.
Key exclusion criteria (3 listed)
- Pregnancy
- Patients included in another study
- Patients that have other solutions that could avoid implantation (medications, ablation, etc
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 |
|---|---|---|
| PacingIn this study we intend to include patients that have indication to and are intended to undergo CRT implantation with an additional electrode on LV, that have inclusion criteria and have signed an informed consent. In this study we will include 20 patients for each study arm (overall 100)- each patient will have both treatment configurations and these two will be compared | Procedure or surgery | biventricular pacing, triventricular pacing |
Primary outcome
Multisite cardiac resynchronization therapy
Time frame: 2 years
In this research we intend to check the efficacy of MSCRT pacing mode in different populations of patients that are not yet included in the published guidelines. Primary end point: Immediate improvement in echo measurements of LVESV of the patient (Each patient is his own control. We expect 15% improvement versus baseline echo measurements or a difference of 5% from one measurements to another).
1 secondary outcome
decrease in arrhythmia burden
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacing in people with Ventricular Tachycardia, run by Barzilai 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multisite cardiac resynchronization therapy (time frame: 2 years). 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 23 Jan 2019.