TachyarrhythmiasSENSE-AFNCT00870324
OptiSense™ Performance in Detecting Atrial Episodes
An observational study of Tachyarrhythmias and Atrial Fibrillation, run by Abbott Medical Devices at 2 sites in United States.
Trial summary
The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachyarrhythmias, Atrial Fibrillation
- What is being tested?
- OptiSense Lead and Tendril Lead
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to Sep 2010
- 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: Patients with approved pacemaker indications.
Who may be able to join
- Patients who meets current ICD or CRT-D implant indications and receive a St. Jude Medical ICD/CRT-D
- Patients who will receive a new St. Jude Medical OptiSense or Tendril RA lead as part of their device implant
Who cannot join
- Patients with a history of Permanent or Persistent AF
- Patient's life expectancy is less than 12 months.
- Patient is pregnant.
- Patient's age at enrollment is less than 18 years.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northeast Ohio Cardiovascular Specialists
Akron, Ohio, 44304
The Ohio State University
Columbus, Ohio, 43210
About this study
Official title: OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population
The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW). The performance of the lead will be measured as a difference in device-determined time in AT/AF and surface-ECG determined time in AT/AF. This measurement will be compared to the control group which will be randomized to receive SJM's Tendril™ RA leads.
- Conditions
- Tachyarrhythmias, Atrial Fibrillation
- Being tested
- OptiSense Lead, Tendril Lead
- Keywords
- ICD, Tachyarrhythmias, Atrial Fibrillation, Patients who meets current ICD or CRT-D implant indications
- Medical subject headings
- Tachycardia, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiSense LeadDevice
The OptiSense™ Model 1699 lead is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in the right atrium. The tip-to-ring spacing in the OptiSense lead is 1.1mm and "narrow-spaced" compared to the Tendril lead.
Tendril LeadDevice
The Tendril® is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in either the atrium or the ventricle. The tip-to-ring spacing in the Tendril is "wide spaced" compared to the OptiSense lead.
| Study group | Role | What they receive |
|---|---|---|
| 1. Control | Patients will receive the Tendril (wide-spaced) lead as part of their ICD implant Receives: Device: Tendril Lead | |
| 2. Experimental | Patients will receive the OptiSense (narrow-spaced) lead as part of their ICD implant Receives: Device: OptiSense Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is the difference in duration between the device-determined time in AF (Device Duration) and the ECG-determined time in AF (ECG Duration).
Measured: 3 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachyarrhythmiasStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870324
- Sponsor's protocol ID
- CRD459
- Acronym
- SENSE-AF
- Status last verified
- Feb 2019
- First submitted
- 25 Mar 2009
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population
- ClinicalTrials.gov ID
- NCT00870324
- Acronym / sponsor ID
- SENSE-AF / CRD459
- Conditions
- Tachyarrhythmias, Atrial Fibrillation
- Keywords
- ICD, Tachyarrhythmias, Atrial Fibrillation, Patients who meets current ICD or CRT-D implant indications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Mar 2009 (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 SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW). The performance of the lead will be measured as a difference in device-determined time in AT/AF and surface-ECG determined time in AT/AF. This measurement will be compared to the control group which will be randomized to receive SJM's Tendril™ RA leads.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Control | – | Device: Tendril LeadPatients will receive the Tendril (wide-spaced) lead as part of their ICD implant |
| 2. Experimental | – | Device: OptiSense LeadPatients will receive the OptiSense (narrow-spaced) lead as part of their ICD implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with approved pacemaker indications.
Key inclusion criteria (2 listed)
- Patients who meets current ICD or CRT-D implant indications and receive a St. Jude Medical ICD/CRT-D
- Patients who will receive a new St. Jude Medical OptiSense or Tendril RA lead as part of their device implant
Key exclusion criteria (4 listed)
- Patients with a history of Permanent or Persistent AF
- Patient's life expectancy is less than 12 months.
- Patient is pregnant.
- Patient's age at enrollment is less than 18 years.
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 |
|---|---|---|
| OptiSense LeadThe OptiSense™ Model 1699 lead is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in the right atrium. The tip-to-ring spacing in the OptiSense lead is 1.1mm and "narrow-spaced" compared to the Tendril lead. | Device | 2. Experimental |
| Tendril LeadThe Tendril® is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in either the atrium or the ventricle. The tip-to-ring spacing in the Tendril is "wide spaced" compared to the OptiSense lead. | Device | 1. Control |
Primary outcome
The primary endpoint of the study is the difference in duration between the device-determined time in AF (Device Duration) and the ECG-determined time in AF (ECG Duration).
Time frame: 3 months post-implant
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 4 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachyarrhythmias and Atrial Fibrillation, run by Abbott Medical Devices at 2 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 2 inclusion and 4 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The primary endpoint of the study is the difference in duration between the device-determined time in AF (Device Duration) and the ECG-determined time in AF (ECG Duration). (time frame: 3 months post-implant). 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 4 Feb 2019.