Clinical trial NCT01983293: CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-left Bundle Branch Block
Ischemic or Non-ischemic Cardiomyopathy
Keywords: Non-left bundle branch block
QLV
LV lead pacing location
CRT-D
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With Improved Clinical Composite Score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Mission Viejo
country: United States
facility: Mission Hospital
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Jacksonville
country: United States
facility: Baker-Gilmour Cardiovascular Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Riverdale
country: United States
facility: Atlanta Heart Associates - Riverdale
state: Georgia
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Oschner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren Macomb
state: Michigan
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Lincoln
country: United States
facility: Bryan LGH Heart Institute
state: Nebraska
city: Manhasset
country: United States
facility: Northshore University Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Germantown
country: United States
facility: Sutherland Cardiology Clinic
state: Tennessee
city: Kingsport
country: United States
facility: Cardiovascular Associates, PC
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Plano
country: United States
facility: Baylor Regional Center at Plano
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg General Hospital
state: Virginia
city: Midlothian
country: United States
facility: Cardiovascular Associates of Virginia
state: Virginia
Study officials:
affiliation: Massachusetts General Hospital
name: Jagmeet Singh, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.