Heart Failure Clinical Trial
Evaluation of Left Ventricular AutoThreshold
Summary
This study will collect data on a new feature for future heart failure devices via an external non-implantable system.
Full Description
ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold feature.
Eligibility Criteria
Inclusion Criteria:
Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
Patients who are willing and capable of participating in all testing associated with this study
Patients who are 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria:
Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, 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 (unless the Investigator intends to replace them with permitted leads)
Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
Patients with a prosthetic mechanical tricuspid heart valve
Women who are pregnant
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There are 2 Locations for this study
Richmond Virginia, 23298, United States
Morgantown West Virginia, 26505, United States
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