Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sensing Atrial High Rate Episodes With DX System in Implantable Cardioverter Defibrillators Trial

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: ICD with DX system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICD with DX system<br>Implantable cardioverter-defibrillator recipients with DX system | Device: ICD with DX system<br>* Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.<br>* Other names: Future FDA-approved Biotronik DX-capable ICD and leads;|
| Dual chamber ICD<br>Dual chamber implantable-cardioverter-defibrillator recipients (retrospective cohort from IMPACT study) | |
| Single chamber ICD<br>Single chamber implantable cardioverter-defibrillator recipients (retrospective cohort from Cornell registry) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial High Rate Episode | Atrial high rate episode > 30 seconds in duration | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Sensing (DX System) | P wave amplitudes measured by DX lead system | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Implantable Defibrillators, Implanted Electrodes