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

Completed

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT02186704

Run by

Weill Medical College of Cornell University

People needed

450

Starts

2014-07-01

Expected to finish

2018-07-01

Last updated by the study team

2018-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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