Status:
COMPLETED
Evaluation of Left Ventricular Autothreshold, Phase Two
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
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 Thr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01242722
Start Date
November 1 2010
End Date
March 1 2011
Last Update
October 3 2012
Active Locations (1)
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1
Regional Cardiovascular Medical Center
Stuebenville, Ohio, United States, 43952