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

Atrial Fibrillation Clinical Trial

— SENSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186704
• Other study ID #: 1401014661
• Status: Completed
• Start date: July 2014
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: July 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• ICD with DX system
Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Ohio State Wexner University Medical Center	Columbus	Ohio
United States	Vanderbilt University	Nashville	Tennessee
United States	Weill Cornell Medical College	New York	New York
United States	Einstein Medical Center	Philadelphia	Pennsylvania
United States	Promedica Heart and Vascular Institute	Toledo	Ohio
United States	Westchester Medical Center	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Atrial High Rate Episode > 6 Minutes (DX System)	Detection of AHRE > 6 minutes duration by DX lead system	1 year
Primary	Atrial High Rate Episode	Atrial high rate episode > 30 seconds in duration	1 year
Secondary	Atrial Sensing (DX System)	P wave amplitudes measured by DX lead system	1 year