CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT)
Non-left Bundle Branch Block, Ischemic or Non-ischemic Cardiomyopathy
About this trial
This is an interventional treatment trial for Non-left Bundle Branch Block focused on measuring Non-left bundle branch block, QLV, LV lead pacing location, CRT-D
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
Sites / Locations
- Glendale Adventist Medical Center
- USC University Hospital
- Mission Hospital
- St. Joseph's Medical Center
- Baker-Gilmour Cardiovascular Institute
- Northside Hospital
- Piedmont Heart Institute
- Emory University Hospital
- Atlanta Heart Associates - Riverdale
- Central Baptist Hospital
- University of Kentucky
- Oschner Medical Center
- Johns Hopkins University Hospital
- Tufts Medical Center
- Massachusetts General Hospital
- Henry Ford Hospital
- St. John Hospital and Medical Center
- McLaren Macomb
- United Hospital
- North Mississippi Medical Center
- Bryan LGH Heart Institute
- Northshore University Hospital
- University of Rochester Medical Center
- Stony Brook University Medical Center
- The Ohio State University
- Sutherland Cardiology Clinic
- Cardiovascular Associates, PC
- Baptist Memorial Hospital
- Baylor Regional Center at Plano
- Inova Fairfax Hospital
- Lynchburg General Hospital
- Cardiovascular Associates of Virginia
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
QLV based implant strategy
Standard of care 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.
The placement of LV lead will be carried out according to the physician's standard of care implant approach.