An observational study in Atrial Fibrillation, sponsored by Weill Medical College of Cornell University. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-28.
Sponsored by Weill Medical College of Cornell University · Observational
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 450 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with standard indications for implantable cardioverter-defibrillator implantation and no prior history of atrial fibrillation
Exclusion Criteria:
Implantable cardioverter-defibrillator recipients with DX system
Device: ICD with DX system
Dual chamber implantable-cardioverter-defibrillator recipients (retrospective cohort from IMPACT study)
Single chamber implantable cardioverter-defibrillator recipients (retrospective cohort from Cornell registry)
Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.
Also known as: Biotronik Ilesto 7 VR-T ICD, Biotronik Lumax Smart S DX ICD lead, Future FDA-approved Biotronik DX-capable ICD and leads
Atrial High Rate Episode
Atrial high rate episode \> 30 seconds in duration
Time frame: 1 year
Atrial Sensing (DX System)
P wave amplitudes measured by DX lead system
Time frame: 1 year
Atrial High Rate Episode > 6 Minutes (DX System)
Detection of AHRE \> 6 minutes duration by DX lead system
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University