Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT01983293
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01983293
Study Brief:
Protocol Section:
NCT01983293