Back to resultsEfficacy and Safety of Multisite Cardiac Resynchronization Therapy
Primary Purpose
Ventricular Tachycardia
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pacing
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring LV- Left Ventricular, CRT- Cardiac resynchronization therapy, MSCRT- Multisite Cardiac resynchronization therapy (P-pacemaker; D-defibrillator), BBB -bundle branch block
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
Pregnancy
- Patients included in another study
- Patients that have other solutions that could avoid implantation (medications, ablation, etc
Sites / Locations
- Barzilai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
biventricular pacing
triventricular pacing
Arm Description
The first configuration will be biventricular pacing (RV and postero-lateral branch of CS for LV pacing), as accepted
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01966016
First Posted
August 26, 2013
Last Updated
January 20, 2019
Sponsor
Barzilai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01966016
Brief Title
Efficacy and Safety of Multisite Cardiac Resynchronization Therapy
Official Title
Efficacy and Safety of Multisite Cardiac Resynchronization Therapy - a Prospective Single Center Study in Selected Patient Population
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 20, 2012 (Actual)
Primary Completion Date
November 17, 2015 (Actual)
Study Completion Date
November 17, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barzilai Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
LV- Left Ventricular, CRT- Cardiac resynchronization therapy, MSCRT- Multisite Cardiac resynchronization therapy (P-pacemaker; D-defibrillator), BBB -bundle branch block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
biventricular pacing
Arm Type
Experimental
Arm Description
The first configuration will be biventricular pacing (RV and postero-lateral branch of CS for LV pacing), as accepted
Arm Title
triventricular pacing
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Pacing
Intervention Description
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
Primary Outcome Measure Information:
Title
Multisite cardiac resynchronization therapy
Description
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).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
decrease in arrhythmia burden
Description
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.
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Pregnancy
Patients included in another study
Patients that have other solutions that could avoid implantation (medications, ablation, etc
Facility Information:
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Multisite Cardiac Resynchronization Therapy
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