ArrhythmiasNCT03110146
EnSite Precision 2.1 Feasibility Study
An observational study of Arrhythmias, run by Abbott Medical Devices.
Trial summary
The objective is to demonstrate feasibility of new 'Magnetic Primary' catheter tracking algorithms within the Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1 The secondary objective is to evaluate catheter rendering in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias
- What is being tested?
- EnSite Precision
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2017to 1 Feb 2019
- How long will I take part?
- 1 Day
- 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: Any patient undergoing a cardiac EP mapping and ablation procedure in which a SJM sensor-enabled catheter and the EnSite Precision Cardiac Mapping system is used, is considered eligible for enrollment.
Who may be able to join
- Patients indicated for a cardiac EP study and ablation procedure using a 3D mapping system.
- Over 18 years of age
- Ability to provide informed consent for study participation and be willing and able to comply with the protocol described evaluations.
Who cannot join
- Pregnant or possibly pregnant patients
About this study
The objective is to demonstrate feasibility of new 'Magnetic Primary' catheter tracking algorithms within the Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1
The secondary objective is to evaluate catheter rendering in the VRP system.
Read the detailed description
This is an acute, multi-center, observational, prospective feasibility study with up to 80 patients at up to 5 centers in Europe.
Data will be simultaneously collected on both the EnSite Precision 2.0.1 and VRP mapping systems for the entire duration of the EP mapping and ablation procedure. This study will not require significant change to the current clinical workflow of the mapping and ablation procedure. The VRP operator will observe both displays in real-time and will enter extensive electronic annotations to the VRP data stream to facilitate retrospective analysis. Examples of annotations include drug administration, patient movement, and the introduction of devices such as an intracardiac Echography (ICE) catheter which are not visible on the EnSite mapping system.
If/when the VRP operator notices events which might be better understood with additional data, he/she might ask the physician to hold a catheter in a stable position for an extra few seconds and/or move the catheter to another position. Examples of such events include catheters appearing outside the 3D model and unrealistic catheter shapes on either display. Compliance with such requests is optional and subject to physician preference.
Retrospective data analysis will focus on characterization of the following:
- Occurence rates and potential causes for Shift and Drift.
- Frequency and severity of discrepancies between impedance and magnetic coordinates.
- Positions of catheters relative to the 3D model.
- Positions of catheters relative to each other, comparing to fluoroscopic images when available.
- Shapes of catheters on the research system as the catheters are moved to different locations.
- Final geometry apprearance on the VRP.
- Voltage and timing maps appearance on the VRP.
- Conditions
- Arrhythmias
- Being tested
- EnSite Precision
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnSite PrecisionDevice
Ablation procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate feasibility of new algorithms witihn the EnSite Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1.
Demonstrate feasibility of new algorithms within the EnSite Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start4 Jan 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiasStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110146
- Sponsor's protocol ID
- SJM-CIP-10173
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EnSite Precision 2.1 Feasibility Study
- ClinicalTrials.gov ID
- NCT03110146
- Acronym / sponsor ID
- SJM-CIP-10173
- Conditions
- Arrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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 objective is to demonstrate feasibility of new 'Magnetic Primary' catheter tracking algorithms within the Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1
The secondary objective is to evaluate catheter rendering in the VRP system.
Detailed description
This is an acute, multi-center, observational, prospective feasibility study with up to 80 patients at up to 5 centers in Europe.
Data will be simultaneously collected on both the EnSite Precision 2.0.1 and VRP mapping systems for the entire duration of the EP mapping and ablation procedure. This study will not require significant change to the current clinical workflow of the mapping and ablation procedure. The VRP operator will observe both displays in real-time and will enter extensive electronic annotations to the VRP data stream to facilitate retrospective analysis. Examples of annotations include drug administration, patient movement, and the introduction of devices such as an intracardiac Echography (ICE) catheter which are not visible on the EnSite mapping system.
If/when the VRP operator notices events which might be better understood with additional data, he/she might ask the physician to hold a catheter in a stable position for an extra few seconds and/or move the catheter to another position. Examples of such events include catheters appearing outside the 3D model and unrealistic catheter shapes on either display. Compliance with such requests is optional and subject to physician preference.
Retrospective data analysis will focus on characterization of the following:
- Occurence rates and potential causes for Shift and Drift.
- Frequency and severity of discrepancies between impedance and magnetic coordinates.
- Positions of catheters relative to the 3D model.
- Positions of catheters relative to each other, comparing to fluoroscopic images when available.
- Shapes of catheters on the research system as the catheters are moved to different locations.
- Final geometry apprearance on the VRP.
- Voltage and timing maps appearance on the VRP.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient undergoing a cardiac EP mapping and ablation procedure in which a SJM sensor-enabled catheter and the EnSite Precision Cardiac Mapping system is used, is considered eligible for enrollment.
Key inclusion criteria (3 listed)
- Patients indicated for a cardiac EP study and ablation procedure using a 3D mapping system.
- Over 18 years of age
- Ability to provide informed consent for study participation and be willing and able to comply with the protocol described evaluations.
Key exclusion criteria (1 listed)
- Pregnant or possibly pregnant patients
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 |
|---|---|---|
| EnSite PrecisionAblation procedure | Device | – |
Primary outcome
Demonstrate feasibility of new algorithms witihn the EnSite Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1.
Time frame: Up to 12 months
Demonstrate feasibility of new algorithms within the EnSite Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1
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 12 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, run by Abbott Medical Devices.
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 3 inclusion and 1 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 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Demonstrate feasibility of new algorithms witihn the EnSite Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1. (time frame: Up to 12 months). 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 12 Feb 2019.