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

NCT ID: NCT01983293

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

QLV based implant strategy

Intervention Type: DEVICE

Standard of care implant strategy

The placement of LV lead will be carried out according to the physician's standard of care implant approach.

Group Type: PLACEBO_COMPARATOR

Standard of care implant strategy

Intervention Type: DEVICE

Interventions

QLV based implant strategy

Intervention Type: DEVICE

Standard of care implant strategy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jagmeet Singh, MD, PhD

Role: STUDY_CHAIR

Massachusetts General Hospital

Locations

Glendale Adventist Medical Center

Glendale, California, United States

USC University Hospital

Los Angeles, California, United States

Mission Hospital

Mission Viejo, California, United States

St. Joseph's Medical Center

Stockton, California, United States

Baker-Gilmour Cardiovascular Institute

Jacksonville, Florida, United States

Northside Hospital

St. Petersburg, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Atlanta Heart Associates - Riverdale

Riverdale, Georgia, United States

Central Baptist Hospital

Lexington, Kentucky, United States

University of Kentucky

Lexington, Kentucky, United States

Oschner Medical Center

New Orleans, Louisiana, United States

Johns Hopkins University Hospital

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

St. John Hospital and Medical Center

Detroit, Michigan, United States

McLaren Macomb

Mount Clemens, Michigan, United States

United Hospital

Saint Paul, Minnesota, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Bryan LGH Heart Institute

Lincoln, Nebraska, United States

Northshore University Hospital

Manhasset, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

The Ohio State University

Columbus, Ohio, United States

Sutherland Cardiology Clinic

Germantown, Tennessee, United States

Cardiovascular Associates, PC

Kingsport, Tennessee, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Baylor Regional Center at Plano

Plano, Texas, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Lynchburg General Hospital

Lynchburg, Virginia, United States

Cardiovascular Associates of Virginia

Midlothian, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30264456 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

60037834

Identifier Type: -

Identifier Source: org_study_id