- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02186704
Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial) (SENSE)
Sensing Atrial High Rate Episodes With DX System in Implantable Cardioverter Defibrillators Trial
The primary aim of the "Sensing Atrial High Rate Episodes with DX System in Implantable Cardioverter Defibrillators Trial" (SENSE Trial) is to assess the efficacy of a implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting atrial high rate episodes.
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.
Study Overview
Detailed Description
The SENSE Trial is designed to study the efficacy of the DX System in detection of atrial high rate episodes (AHREs) in subjects with no prior history of atrial fibrillation. The DX System, or "DX," consists of a Biotronik DX ICD, and the Biotronik Linox Smart S DX lead which is an FDA approved ICD system that incorporates use of an implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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New York
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New York, New York, United States, 10021
- Weill Cornell Medical College
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Valhalla, New York, United States, 10532
- Westchester Medical Center
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State Wexner University Medical Center
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Toledo, Ohio, United States, 43615
- Promedica Heart and Vascular Institute
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
- Einstein Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Fulfills standard indications for ICD implantation
- 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 prior diagnosis of atrial fibrillation or atrial flutter
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ICD with DX system
Implantable cardioverter-defibrillator recipients with DX system
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Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.
Other Names:
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Dual chamber ICD
Dual chamber implantable-cardioverter-defibrillator recipients (retrospective cohort from IMPACT study)
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Single chamber ICD
Single chamber implantable cardioverter-defibrillator recipients (retrospective cohort from Cornell registry)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Atrial High Rate Episode
Time Frame: 1 year
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Atrial high rate episode > 30 seconds in duration
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Atrial Sensing (DX System)
Time Frame: 1 year
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P wave amplitudes measured by DX lead system
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1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Atrial High Rate Episode > 6 Minutes (DX System)
Time Frame: 1 year
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Detection of AHRE > 6 minutes duration by DX lead system
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1 year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: George Thomas, MD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1401014661
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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