Atrial FibrillationSENSENCT02186704
Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)
An observational study of Atrial Fibrillation, run by Weill Medical College of Cornell University at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ICD with DX system
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2014to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with standard indications for implantable cardioverter-defibrillator implantation and no prior history of atrial fibrillation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Ohio State Wexner University Medical Center
Columbus, Ohio, 43210
Vanderbilt University
Nashville, Tennessee, 37232
Weill Cornell Medical College
New York, New York, 10021
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Promedica Heart and Vascular Institute
Toledo, Ohio, 43615
Westchester Medical Center
Valhalla, New York, 10532
About this study
Official title: Sensing Atrial High Rate Episodes With DX System in Implantable Cardioverter Defibrillators Trial
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- ICD with DX system
- Keywords
- Atrial Fibrillation, Implantable Defibrillators, Implanted Electrodes
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD with DX systemDevice
Also called Biotronik Ilesto 7 VR-T ICD, Biotronik Lumax Smart S DX ICD lead, Future FDA-approved Biotronik DX-capable ICD and leads
Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.
| Study group | Role | What they receive |
|---|---|---|
| ICD with DX system | Implantable cardioverter-defibrillator recipients with DX system Receives: Device: ICD with DX system | |
| Dual chamber ICD | Dual chamber implantable-cardioverter-defibrillator recipients (retrospective cohort from IMPACT study) | |
| Single chamber ICD | Single chamber implantable cardioverter-defibrillator recipients (retrospective cohort from Cornell registry) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial High Rate Episode
Atrial high rate episode > 30 seconds in duration
Measured: 1 year
Secondary outcomes (1)
Atrial Sensing (DX System)
P wave amplitudes measured by DX lead system
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik, Inc.
- Responsible party
- Sponsor
- Investigators
- George Thomas, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186704
- Sponsor's protocol ID
- 1401014661
- Acronym
- SENSE
- Status last verified
- Aug 2018
- First submitted
- 7 Jul 2014
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensing Atrial High Rate Episodes With DX System in Implantable Cardioverter Defibrillators Trial
- ClinicalTrials.gov ID
- NCT02186704
- Acronym / sponsor ID
- SENSE / 1401014661
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Implantable Defibrillators, Implanted Electrodes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Biotronik, Inc.
- Study start
- Jul 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICD with DX system | – | Device: ICD with DX systemImplantable cardioverter-defibrillator recipients with DX system |
| Dual chamber ICD | – | –Dual chamber implantable-cardioverter-defibrillator recipients (retrospective cohort from IMPACT study) |
| Single chamber ICD | – | –Single chamber implantable cardioverter-defibrillator recipients (retrospective cohort from Cornell registry) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with standard indications for implantable cardioverter-defibrillator implantation and no prior history of atrial fibrillation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD with DX systemAlso: Biotronik Ilesto 7 VR-T ICD, Biotronik Lumax Smart S DX ICD lead, Future FDA-approved Biotronik DX-capable ICD and leadsImplantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole. | Device | ICD with DX system |
Primary outcome
Atrial High Rate Episode
Time frame: 1 year
Atrial high rate episode > 30 seconds in duration
1 secondary outcome
Atrial Sensing (DX System)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Thomas, MD principal investigator
Weill Medical College of Cornell University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Weill Medical College of Cornell University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial High Rate Episode (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.