CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (NCT01983293) | Clinical Trial Compass
CompletedNot Applicable
CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients
United States248 participantsStarted 2013-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 t…
What they're measuring
1
Number of Patients With Improved Clinical Composite Score