CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients

Not Applicable

Completed

Conditions: Ischemic or Non-ischemic Cardiomyopathy
Non-left Bundle Branch Block

Interventions: Device: Standard of care implant strategy
Device: QLV based implant strategy

Registration Number: NCT01983293

Lead Sponsor: Abbott Medical Devices

Brief Summary: The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.

Detailed Description: This is a prospective, pilot, multi-center, double-blinded, randomized post-market study to assess the effect of left ventricular lead pacing location (guided via QLV measurement vs. standard of care approach) in non-LBBB patients.

In the QLV arm the physician will:

1. Assess two branches of the coronary sinus - a non-traditional vessel (inclusive of the anterior region) will be tested first and a traditional free lateral branch will be tested second for LV lead placement.

2. Measure QLV for each of the four cathodes of the left ventricular lead in each branch.

3. Choose the vein branch and cathode with the longest QLV measurement and program a vector based on that cathode.

In the standard of care group, the left ventricular lead placement will be carried out according to the physician's standard of care implant approach.

The impact of the left ventricular lead position will be evaluated based on the patient's response to CRT utilizing the Clinical Composite Score (cardiovascular death, heart failure hospitalizations, New York Heart Association (NYHA) class, and Patient Global Assessment). Authorized site personnel conducting the NYHA class assessment and Patient Global Assessment will be blinded to the randomization assignment and lead implant technique.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 248

Inclusion Criteria

Have non-LBBB morphology (includes complete right bundle branch block and intraventricular conduction delay with a QRS duration ≥ 120ms)
Have the following indication per the 2013 updated American College of Cardiology Foundation/American Heart Association/Heart Rhythm Society guidelines:
- Left ventricular ejection fraction (LVEF) ≤ 35%, sinus rhythm, ischemic or non-ischemic cardiomyopathy, a non-LBBB pattern with QRS duration ≥ 120 ms, and NYHA) class III/ambulatory class IV on guideline directed medical therapy
Receiving a new CRT implant or undergoing an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant with no more than 10% right ventricular pacing
Are 18 years or older, or of legal age to give informed consent specific to state and local law
Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria

Irreversible occlusion of venous access that will prevent placement of the CRT system either through the right or left upper extremity venous system
Undergoing left ventricular lead placement via a surgical or epicardial approach
Cardiomyopathy due solely to valvular disease that is not repaired/replaced
Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by St. Jude Medical, during the course of this clinical study
LBBB: QRS width ≥ 120 ms, with predominantly negative QRS in lead V1, and upright, monophasic QRS in leads I and V6
Incomplete right bundle branch block - intraventricular conduction delay with a QRS duration between 110 and 119ms
Persistent or permanent atrial fibrillation
Pacemaker dependent
Patients who are being upgraded primarily due to right ventricular pacing
Women who are pregnant or who plan to become pregnant during the clinical trial
Life expectancy < 1 year

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care implant strategy	Standard of care implant strategy	The placement of LV lead will be carried out according to the physician's standard of care implant approach.
QLV based implant strategy	QLV based implant strategy	QLV represents the pacing site with the largest amount of dyssynchrony as measured by the left ventricular electrical delay. The QLV based implant strategy finds the left ventricle vein branch and left ventricular lead cathode with the longest QLV measurement and places the lead at this location and programs the device using this lead cathode.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Improved Clinical Composite Score	12 months	Evaluate the Clinical Composite Score (CCS) at 12 months in NLBBB patients using a standard of care vs. latest electrical delay (QLV) implant strategy. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (32): Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
North Mississippi Medical Center
🇺🇸
Tupelo, Mississippi, United States
Cardiovascular Associates, PC
🇺🇸
Kingsport, Tennessee, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Mission Hospital
🇺🇸
Mission Viejo, California, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Sutherland Cardiology Clinic
🇺🇸
Germantown, Tennessee, United States
Inova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
St. John Hospital and Medical Center
🇺🇸
Detroit, Michigan, United States
Northshore University Hospital
🇺🇸
Manhasset, New York, United States
University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
Bryan LGH Heart Institute
🇺🇸
Lincoln, Nebraska, United States
Lynchburg General Hospital
🇺🇸
Lynchburg, Virginia, United States
Stony Brook University Medical Center
🇺🇸
Stony Brook, New York, United States
Baylor Regional Center at Plano
🇺🇸
Plano, Texas, United States
St. Joseph's Medical Center
🇺🇸
Stockton, California, United States
Baptist Memorial Hospital
🇺🇸
Memphis, Tennessee, United States
The Ohio State University
🇺🇸
Columbus, Ohio, United States
Cardiovascular Associates of Virginia
🇺🇸
Midlothian, Virginia, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
USC University Hospital
🇺🇸
Los Angeles, California, United States
Johns Hopkins University Hospital
🇺🇸
Baltimore, Maryland, United States
Glendale Adventist Medical Center
🇺🇸
Glendale, California, United States
Atlanta Heart Associates - Riverdale
🇺🇸
Riverdale, Georgia, United States
United Hospital
🇺🇸
Saint Paul, Minnesota, United States
Baker-Gilmour Cardiovascular Institute
🇺🇸
Jacksonville, Florida, United States
Central Baptist Hospital
🇺🇸
Lexington, Kentucky, United States
Oschner Medical Center
🇺🇸
New Orleans, Louisiana, United States
Northside Hospital
🇺🇸
Saint Petersburg, Florida, United States
McLaren Macomb
🇺🇸
Mount Clemens, Michigan, United States