Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)
SENSE
1 other identifier
observational
450
1 country
8
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-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 7, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 28, 2018
August 1, 2018
3.7 years
July 7, 2014
August 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Atrial High Rate Episode
Atrial high rate episode \> 30 seconds in duration
1 year
Secondary Outcomes (1)
Atrial Sensing (DX System)
1 year
Other Outcomes (1)
Atrial High Rate Episode > 6 Minutes (DX System)
1 year
Study Arms (3)
ICD with DX system
Implantable cardioverter-defibrillator recipients with DX system
Dual chamber ICD
Dual chamber implantable-cardioverter-defibrillator recipients (retrospective cohort from IMPACT study)
Single chamber ICD
Single chamber implantable cardioverter-defibrillator recipients (retrospective cohort from Cornell registry)
Interventions
Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.
Eligibility Criteria
Subjects with standard indications for implantable cardioverter-defibrillator implantation and no prior history of atrial fibrillation
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Weill Medical College of Cornell Universitylead
- Biotronik, Inc.collaborator
Study Sites (8)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Westchester Medical Center
Valhalla, New York, 10532, United States
The Ohio State Wexner University Medical Center
Columbus, Ohio, 43210, United States
Promedica Heart and Vascular Institute
Toledo, Ohio, 43615, United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George Thomas, MD
Weill Medical College of Cornell University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2014
First Posted
July 10, 2014
Study Start
July 1, 2014
Primary Completion
March 1, 2018
Study Completion
July 1, 2018
Last Updated
August 28, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share