This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.
ELEVATE 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold (LVAT) feature.
Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without a right atrial lead Patients who have an active LV bipolar lead Patients who have an active right ventricular (RV) defibrillation lead Patients who are willing and capable of participating in all testing associated with this Clinical Investigation Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria:
Patients who have a COGNIS CRT-D that has less than or equal to one year of battery life remaining Patients who are pacemaker-dependent Patients who will not tolerate a pacing pause of up to 6 seconds Patients who have a unipolar LV pace/sense lead, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads) Patients with pre-existing leads other than those specified in this investigational plan Patients with a pre-existing unipolar pacemaker Patients who are unable or unwilling to maintain a supine or sitting position for 40-50 minutes Patients enrolled in any concurrent study, without Boston Scientific written approval Women who are pregnant
