Evaluation of Left Ventricular Autothreshold, Phase Two
NCT ID: NCT01242722
Last Updated: 2012-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2010-11-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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1
Two experimental and/or intervention groups under 1 arm.
CRT-D
Cardiac pacing via a pulse generator and implanted intracardiac leads
Interventions
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CRT-D
Cardiac pacing via a pulse generator and implanted intracardiac leads
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth L Ellenbogen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University Health System
Locations
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Regional Cardiovascular Medical Center
Stuebenville, Ohio, United States
Countries
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Other Identifiers
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ELEVATE 2.0
Identifier Type: -
Identifier Source: org_study_id