Efficacy and Safety of Multisite Cardiac Resynchronization Therapy (no)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Barzilai Medical Center
Sponsor:
Information provided by (Responsible Party):
avishag laish-farkash, Barzilai Medical Center
ClinicalTrials.gov Identifier:
NCT01966016
First received: August 26, 2013
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Ventricular Tachycardia
Procedure: Pacing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Multisite Cardiac Resynchronization Therapy - a Prospective Single Center Study in Selected Patient Population

Resource links provided by NLM:


Further study details as provided by Barzilai Medical Center:

Primary Outcome Measures:
  • Multisite cardiac resynchronization therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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 [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: biventricular pacing
The first configuration will be biventricular pacing (RV and postero-lateral branch of CS for LV pacing), as accepted
Procedure: Pacing

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

Experimental: triventricular pacing
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

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


  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Patients with conventional indications for CRTD implantation and EF<25%, QRS>150ms and severe heart failure (NYHA FC>III).
  3. 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).
  4. 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.
  5. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966016

Contacts
Contact: Avishag Laish-Farkash, MD avishagl@barzi.health.gov.il
Contact: Ornit Cohen, Msc ornitc@barzi.health.gov.il

Locations
Israel
Barzilai Medical Center Recruiting
Ashkelon, Israel
Contact: Avishag Laish-Farkash, MD, PhD       avishagl@barzi.health.gov.il   
Contact: Ornit Cohen, Msc       ornitc@barzi.health.gov.il   
Principal Investigator: Avishag Laish-Farkash, MD, PhD         
Sponsors and Collaborators
Barzilai Medical Center
  More Information

No publications provided

Responsible Party: avishag laish-farkash, Electrophysiologist MD PhD, Barzilai Medical Center
ClinicalTrials.gov Identifier: NCT01966016     History of Changes
Other Study ID Numbers: BRZ0046-12CTIL
Study First Received: August 26, 2013
Last Updated: October 16, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Barzilai Medical Center:
LV- Left Ventricular
CRT- Cardiac resynchronization therapy
MSCRT- Multisite Cardiac resynchronization therapy (P-pacemaker; D-defibrillator)
BBB -bundle branch block

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014