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

Weill Cornell Medicine (WCM)

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Device: ICD with DX system

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02186704

1401014661

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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