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Correlating QLV Interval to Left Ventricular (LV) Lead Position in Patients Receiving Cardiac Resynchronization Therapy.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of California, San Diego
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Ulrika Birgersdotter-Green, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02166762
First received: June 16, 2014
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

This is a prospective clinical trial to determine the optimal QLV interval during implantation to achieve the best possible response from cardiac resynchronization therapy for heart failure patients.


Condition Intervention
Heart Failure
Cardiomyopathy
Procedure: QLV interval measurement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mapping of the Coronary Venous System in Patients With Heart Failure Presenting for CRT-D (Cardiac Resynchronization Therapy) Implantation. Correlating QLV Interval to Fluoroscopic LV (Left Ventricular) Lead Position.

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • QLV measurement [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Measurements of the QLV interval is defined from the onset of the QRS width of the surface ECG to the first large positive or negative peak of the LV electrogram (EGM) during a cardiac cycle.


Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QLV interval measurement
QLV measurements collected during implantation of CRT-D device
Procedure: QLV interval measurement
Measurements of the QLV interval is defined from the onset of the QRS width of the surface ECG to the first large positive or negative peak of the LV EGM during a cardiac cycle. Recorded EGM's will be measured at three distinct points (basal, mid, and distal) within each target vessel.

Detailed Description:

Heart failure is a growing epidemic in the United States. Heart failure is associated with shortness of breath, reduced exercise tolerance, and manifestations of peripheral fluid retention. As the disease progresses, there is development of cardiac dyssynchrony (failure of the heart to act as one unit) in the electrical and mechanical functions of the myocardium.

During implantation of a cardiac resynchronization therapy defibrillator (CRT-D) device, three electrical wires are placed in the right atrium (RA), right ventricle (RV) and coronary venous system that drains blood from the left ventricle (LV). The LV lead is placed in the posterolateral tributaries of the coronary venous system using special delivery tools. Pacing therapies to resynchronize the heart have been shown to improve functional class and mortality in patients with severe heart failure i.e. New York Heart Association (NYHA) class III and IV functional status. Current indications for cardiac resynchronization therapy (CRT-D) include severe cardiomyopathy (Ejection Fraction < 35%), with shortness of breath at rest or minimal exertion (NYHA class II, IV), prolonged QRS > 130ms on surface echocardiogram (ECG) and life expectancy more than one year. CRT-D therapy results in decrease of heart failure admissions and improvements in quality of life.

Response to CRT is associated with improvement in functional status by one NYHA functional class schema or by evidence of reverse remodeling (decrease in end systolic LV dimension by 15%). However across clinical trials, a third of the patients are non-responders to CRT therapy. Non-ischemic etiology of heart failure and presence of electrical dyssynchrony on surface ECG suggested by QRS >150ms are associated with better response with CRT. Non response to CRT can be due to inappropriate patient selection, inappropriate device programming, and inappropriate lead placement. However, inappropriate lead placement is the factor that can be changed during device implantation. Adverse changes in morality and heart failure can occur with sub-optimal position of the LV lead. Most echocardiographic parameters to predict responders were not clinically useful. Appropriate positioning near the area of the heart with latest activation (usually posterolateral segment of the left ventricle) is associated with better response. Inter-ventricular delay as measured by the time delay between the two leads in the left and right ventricles (RV-LV delay) was shown to be a better predictor of response. Interval from the first deflection of the surface ECG to the bipolar electrogram (QLV interval) can be used as a surrogate to identify the delayed segments of the left ventricle. Preliminary studies have shown better response using this approach of lead placement in the regions of latest activation. SMART AV study which used a similar algorithm in assessing delay also showed a trend for better response using QLV interval. However, the fluoroscopic lead position was not correlated with QLV interval for that study. We plan to measure this area of delayed activation to target effective lead placement and map the coronary veins to target the longest QLV interval in each patient.

For this study, medical history and demographic information will be collected from patients as well as clinical information from the procedure. The QLV measurements will be collected prior to implant of LV lead. The QLV interval is defined as the measurement from the onset of the QRS width of the surface ECG to the first large positive or negative peak of the LV electrogram (EGM) during a cardiac cycle. QLV EGM will be taken from either the LV pacing lead and/or .014 wire. QLV EGM's will be measured at three distinct points (basal, mid, and distal) within each target vessel. Each data point will be the average of four to six beats to allow for respiratory variance, and recorded using the Bard mapping system. The final lead position will be the area of vein that has the longest QLV interval with appropriate sensing and pacing thresholds. The QLV measurements will be conducted, in addition to all standard of care procedures for CRT-D implantation for patients enrolled in the clinical trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are indicated for CRT-D devices according to the current guidelines for implantation of cardiac pacemakers and antiarrhythmia devices

Exclusion Criteria:

  • Patients who are under the age of 18
  • Patients who are pregnant
  • Patients who cannot have intravenous contrast due to allergic reactions or chronic renal insufficiency
  • Patients who are unable or unwilling for any reason to consent for this study
  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: NCT02166762

Contacts
Contact: Jessica A Hunter, BHS 858-657-5323 j2hunter@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Jessica Hunter    858-657-5323      
Principal Investigator: Ulrika Birgersdotter-Green, MD         
Sponsors and Collaborators
University of California, San Diego
Boston Scientific Corporation
Investigators
Principal Investigator: Ulrika Birgersdotter-Green, MD UCSD Electrophysiology
  More Information

Publications:

Responsible Party: Ulrika Birgersdotter-Green, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02166762     History of Changes
Other Study ID Numbers: 121099
Study First Received: June 16, 2014
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Cardiac Resynchronization Therapy
Biventricular implantable cardioverter defibrillators
Heart failure
Cardiomyopathy
QLV
LV lead placement

Additional relevant MeSH terms:
Cardiomyopathies
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014