Status:
COMPLETED
Evaluation of Left Ventricular AutoThreshold
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
This study will collect data on a new feature for future heart failure devices via an external non-implantable system.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00812201
Start Date
December 1 2008
End Date
October 1 2009
Last Update
June 28 2022
Active Locations (2)
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1
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
2
Monongalia General Hospital
Morgantown, West Virginia, United States, 26505