Efficacy and Safety of Multisite Cardiac Resynchronization Therapy

NCT01966016 | Completed

• 1 other identifier: BRZ0046-12CTIL
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia

Keywords

LV- Left Ventricular; CRT- Cardiac resynchronization therapy; MSCRT- Multisite Cardiac resynchronization therapy (P-pacemaker; D-defibrillator); BBB -bundle branch block

Outcome Measures

Primary Outcomes (1)

• 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).

  2 years

Secondary Outcomes (1)

• decrease in arrhythmia burden

  up to 1 year

Study Arms (2)

biventricular pacing

EXPERIMENTAL

The first configuration will be biventricular pacing (RV and postero-lateral branch of CS for LV pacing), as accepted

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

Procedure: Pacing

Interventions

Pacing PROCEDURE

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

biventricular pacing; triventricular pacing

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Patients included in another study
• Patients that have other solutions that could avoid implantation (medications, ablation, etc

Sponsors & Collaborators

• Barzilai Medical Center: lead

Study Sites (1)

Barzilai Medical Center

Ashkelon, Israel

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CRA

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: October 21, 2013
• Study Start: November 20, 2012
• Primary Completion: November 17, 2015
• Study Completion: November 17, 2015
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

IL (1)