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

Cardiac Resynchronization Therapy (CRT) Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT). A Prospective, Randomized, Postmarket, Pilot Study.

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.

Study Overview

• Status: Completed
• Conditions: Non-left Bundle Branch Block; Ischemic or Non-ischemic Cardiomyopathy
• Intervention / Treatment: Device: QLV based implant strategy; Device: Standard of care implant strategy

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.

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Glendale Adventist Medical Center
    • Los Angeles, California, United States, 90033
      • USC University Hospital
    • Mission Viejo, California, United States, 92691
      • Mission Hospital
    • Stockton, California, United States, 95204
      • St. Joseph's Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Baker-Gilmour Cardiovascular Institute
    • Saint Petersburg, Florida, United States, 33709
      • Northside Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
    • Riverdale, Georgia, United States, 30274
      • Atlanta Heart Associates - Riverdale
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70448
      • Oschner Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48236
      • St. John Hospital and Medical Center
    • Mount Clemens, Michigan, United States, 48043
      • McLaren Macomb
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • United Hospital
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan LGH Heart Institute
  • New York
    • Manhasset, New York, United States, 11030
      • Northshore University Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Stony Brook, New York, United States, 11790
      • Stony Brook University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Sutherland Cardiology Clinic
    • Kingsport, Tennessee, United States, 37660
      • Cardiovascular Associates, Pc
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
  • Texas
    • Plano, Texas, United States, 75093
      • Baylor Regional Center at Plano
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Lynchburg, Virginia, United States, 24501
      • Lynchburg General Hospital
    • Midlothian, Virginia, United States, 23224
      • Cardiovascular Associates of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: QLV based implant strategy
Placebo Comparator: Standard of care implant strategy; The placement of LV lead will be carried out according to the physician's standard of care implant approach.	Device: Standard of care implant strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Improved Clinical Composite Score	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.	12 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Chair: Jagmeet Singh, MD, PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Singh JP, Berger RD, Doshi RN, Lloyd M, Moore D, Daoud EG; ENHANCE CRT Study Group. Rationale and design for ENHANCE CRT: QLV implant strategy for non-left bundle branch block patients. ESC Heart Fail. 2018 Dec;5(6):1184-1190. doi: 10.1002/ehf2.12340. Epub 2018 Sep 27.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: November 6, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: February 15, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Non-left bundle branch block; QLV; LV lead pacing location; CRT-D
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Bundle-Branch Block; Heart Block; Cardiomyopathies
• Other Study ID Numbers: 60037834

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes