ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0
NCT ID: NCT01539629
Last Updated: 2012-12-05
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
50 participants
OBSERVATIONAL
2012-03-31
2012-11-30
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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Pulse Width
One group reflecting two different pulse widths.
Cardiac pacing
Cadiac pacing via a pulse generator and implaned intracardiac leads.
Interventions
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Cardiac pacing
Cadiac pacing via a pulse generator and implaned intracardiac leads.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without an active right atrial lead
* Patients who have an active LV bipolar or unipolar lead
* Patients who have an active RV defibrillation lead
* Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
Exclusion Criteria
* Patients who are pacemaker-dependent as defined as VVI 40 without intrinsic atrial or ventricular activity
* Patients who will not tolerate a pacing pause of up to 6 seconds
* Patients with a pre-existing unipolar pacemaker
* Patients who are unable or unwilling to maintain a supine or sitting position for 20-50 minutes
* Patients enrolled in any concurrent study, without Boston Scientific CRM written approval
* Women who are pregnant;women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
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, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University Health System
Locations
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Genesis Medical Center
Davenport, Iowa, United States
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
Wheaton Franciscan Health Care
Wauwatosa, Wisconsin, United States
Countries
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Other Identifiers
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ELEVATE 3.0
Identifier Type: -
Identifier Source: org_study_id