Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)
NCT ID: NCT02186704
Last Updated: 2018-08-28
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
450 participants
OBSERVATIONAL
2014-07-31
2018-07-31
Brief Summary
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The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles will have a diagnostic yield comparable to that of a standard dual chamber ICD system and superior to that of a standard single chamber ICD system.
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Detailed Description
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The SENSE Trial will be conducted at 8-12 U.S. sites. The lead coordinating site will be at Weill Cornell Medical College. Subjects will be followed for 1 year to assess for the primary endpoints of the trial.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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ICD with DX system
Implantable cardioverter-defibrillator recipients with DX system
ICD with DX system
Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.
Dual chamber ICD
Dual chamber implantable-cardioverter-defibrillator recipients (retrospective cohort from IMPACT study)
No interventions assigned to this group
Single chamber ICD
Single chamber implantable cardioverter-defibrillator recipients (retrospective cohort from Cornell registry)
No interventions assigned to this group
Interventions
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ICD with DX system
Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject or legally authorized representative can provide written authorization per institutional requirements
* Subject is intended to be implanted with a complete Biotronik DX system (consisting of a Biotronik Ilesto 7 VR-T DX ICD or any future FDA approved Lumax VR-T DX ICD, and the Biotronik Linox Smart S DX lead), or has been implanted with a complete Biotronik DX system no more than 30 days prior to the date of consent
* Able to comply with Home Monitoring
Exclusion Criteria
* Subject has need for atrial pacing
* Subject unwilling or unable to give informed consent or participate in follow-up
* Subject is unable to comply with Home Monitoring
* Subject is pregnant
* Subject has less than one year estimated life expectancy
* Subject was implanted with a cardiac device capable of detecting AHREs prior to implantation of the Biotronik DX system
* Subject was implanted with Biotronik DX system and had an AHRE detection before enrollment
18 Years
ALL
No
Sponsors
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Biotronik, Inc.
INDUSTRY
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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George Thomas, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Weill Cornell Medical College
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
The Ohio State Wexner University Medical Center
Columbus, Ohio, United States
Promedica Heart and Vascular Institute
Toledo, Ohio, United States
Einstein Medical Center
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
Countries
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Other Identifiers
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1401014661
Identifier Type: -
Identifier Source: org_study_id
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