Status:
COMPLETED
Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Biotronik, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
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-defibri...
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," c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT02186704
Start Date
July 1 2014
End Date
July 1 2018
Last Update
August 28 2018
Active Locations (8)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Weill Cornell Medical College
New York, New York, United States, 10021
4
Westchester Medical Center
Valhalla, New York, United States, 10532