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OpenTrials
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NCT Number: NCT01966016

Efficacy and Safety of Multisite Cardiac Resynchronization Therapy

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.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barzilai Medical Center

Ashkelon, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. decrease in arrhythmia burden

    Time frame: up to 1 year

    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.

Sponsors and collaborators

Lead sponsor

Barzilai Medical Center

Other

Registry information

Official study title

Efficacy and Safety of Multisite Cardiac Resynchronization Therapy - a Prospective Single Center Study in Selected Patient Population

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2013
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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