Expired Study
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Stuebenville, Ohio 43952


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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


NCT ID:

NCT01242722


Primary Contact:

Principal Investigator
Kenneth L Ellenbogen, M.D.
Virginia Commonwealth University Health System


Backup Contact:

N/A


Location Contact:

Stuebenville, Ohio 43952
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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