Key Results
Key Result 1
SENSE Clinical Trial
Subclinical atrial fibrillation detection with a floating atrial sensing dipole in single lead implantable cardioverter defibrillator systems: Results of the SENSE trial
THOMAS G ET AL., JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY 2019
doi: 10.1111/JCE.14081
Study Design
- Prospective, multicenter cohort-controlled study
- 150 patients implanted with a BIOTRONIK DX ICD system, comparing data with historical single- and dual-chamber ICD cohorts derived from previous studies
- 8 US centers
- To determine the utility of the DX implantable cardioverter-defibrillator (ICD) system for subclinical atrial fibrillation (AF) detection
Key Result 2
Clinical Relevance
- First study to assess efficacy of DX technology for subclinical AF detection in a prospective, multicenter, cohort-controlled trial.
- The results indicate that the DX ICD system may offer significant benefits for AHRE detection in ICD patients who do not have an atrial pacing indication, but are at high risk of developing subclinical AF
Study Details
Study Objective
- To determine the utility of the DX implantable cardioverter-defibrillator (ICD) system for subclinical atrial fibrillation (AF) detection
Primary Endpoint
- Atrial high rate episode > 30 seconds in duration
Major Secondary Endpoints
- P wave amplitudes measured by DX lead system
- Detection of AHRE > 6 minutes duration by DX lead system
Clinical Sites
- 8 US centers
Sample Size
- 450 participants
Main Inclusion Criteria
- Subject 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
Main 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
Follow-Up
- 12 months follow‐up
Study Duration
- Between 2014 and 2018
Reference no.
- NCT02186704
Principal Investigators
- George Thomas, MD (Weill Medical College of Cornell University, USA)