Clinical trial NCT02186704: Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)
Official title: Sensing Atrial High Rate Episodes With DX System in Implantable Cardioverter Defibrillators Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Implantable Defibrillators
Implanted Electrodes
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Biotronik, Inc.
First posted: 2014-07-10
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with standard indications for implantable cardioverter-defibrillator implantation and no prior history of atrial fibrillation

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.

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," 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.

Eligibility criteria: 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

Primary outcomes:
measure: Atrial High Rate Episode
timeFrame: 1 year
Secondary outcomes:
measure: Atrial Sensing (DX System)
timeFrame: 1 year
Other outcomes:
measure: Atrial High Rate Episode > 6 Minutes (DX System)
timeFrame: 1 year
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Columbus
country: United States
facility: The Ohio State Wexner University Medical Center
state: Ohio
city: Toledo
country: United States
facility: Promedica Heart and Vascular Institute
state: Ohio
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Weill Medical College of Cornell University
name: George Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: