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

NCT01983293 | Completed Results FDA Device

• 1 other identifier: 60037834
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 32

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.

Conditions

Non-left Bundle Branch Block; Ischemic or Non-ischemic Cardiomyopathy

Keywords

Non-left bundle branch block; QLV; LV lead pacing location; CRT-D

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

QLV based implant strategy

EXPERIMENTAL

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

Standard of care implant strategy

PLACEBO COMPARATOR

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

Interventions

QLV based implant strategy DEVICE

QLV based implant strategy

Standard of care implant strategy DEVICE

Standard of care implant strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (32)

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

Mission Hospital

Mission Viejo, California, 92691, United States

Location

St. Joseph's Medical Center

Stockton, California, 95204, United States

Location

Baker-Gilmour Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

Northside Hospital

St. Petersburg, Florida, 33709, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Atlanta Heart Associates - Riverdale

Riverdale, Georgia, 30274, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Oschner Medical Center

New Orleans, Louisiana, 70448, United States

Location

Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

McLaren Macomb

Mount Clemens, Michigan, 48043, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Bryan LGH Heart Institute

Lincoln, Nebraska, 68506, United States

Location

Northshore University Hospital

Manhasset, New York, 11030, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11790, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Sutherland Cardiology Clinic

Germantown, Tennessee, 38138, United States

Location

Cardiovascular Associates, PC

Kingsport, Tennessee, 37660, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Baylor Regional Center at Plano

Plano, Texas, 75093, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Lynchburg General Hospital

Lynchburg, Virginia, 24501, United States

Location

Cardiovascular Associates of Virginia

Midlothian, Virginia, 23224, United States

Location

Related Publications (1)

• 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.

  PMID: 30264456 BACKGROUND

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clay Cohorn
• Organization: Abbott

clay.cohorn@abbott.com

1 972 309 8087

Study Officials

• Jagmeet Singh, MD, PhD

  Massachusetts General Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 13, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 13, 2019
• Results First Posted: January 2, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)