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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT01983293

Run by

Abbott Medical Devices

People needed

248

Starts

2013-11-01

Expected to finish

2018-01-01

Last updated by the study team

2019-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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