Flutter, AtrialNorthstarNCT06359678
The Northstar Trial
A study testing NorthStar in people with Flutter, Atrial, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The introduction of real-time MRI-guided cardiac ablation therapy, a significant advancement in interventional medicine, necessitates precise catheter tracking for accurate navigation within the complex cardiac anatomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flutter, Atrial
- What is being tested?
- NorthStar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patients undergoing a real-time MRI-guided flutter ablation procedure at the Amsterdam UMC.
Who cannot join
- Lack of legal capacity.
- Insufficient proficiency in the Dutch language.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Marco Gotte
About this study
Official title: Assessing the Accuracy of Catheter Localization With NorthStar Software in Real-Time MRI-Guided Cardiac Ablation
The introduction of real-time MRI-guided cardiac ablation therapy, a significant advancement in interventional medicine, necessitates precise catheter tracking for accurate navigation within the complex cardiac anatomy. The introduction of the NorthStar software as an active tracking system holds promise for improving the precision and efficiency of catheter manipulation during these procedures. However, a rigorous evaluation of its accuracy and reliability in a clinical setting is crucial to validate its viability.
The objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during real-time MRI-guided cardiac ablation therapy.
- Conditions
- Flutter, Atrial
- Being tested
- NorthStar
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorthStarDevice
Throughout the real-time MRI-guided ablation procedure, the operator will assess the precision of the NorthStar 3D navigation software. Before commencing the actual ablation, the operator will confirm the alignment of the 3D anatomical shell, generated in NorthStar through specific electrical signals. Post the ablation procedure, a secondary alignment verification will be conducted to detect any potential drift or shift.
| Study group | Role | What they receive |
|---|---|---|
| Northstar | Experimental | This is the study group Receives: Device: NorthStar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Catheter Localization
The primary objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during realtime MRI-guided cardiac ablation therapy. At the start of the procedure, the catheters will be manoeuvred to the predefined areas within the right side of the heart based on the specific electrical signals in that area. These locations will be virtually marked within the NorthStar software. The extent to which these markers maintain their spatial coordinates after the ablation procedure, evaluated by obtained electrical signals, will serve as a quantitative measure of the system's accuracy.
Measured: during procedure
Secondary outcomes (4)
Influences of breathing pattern
To investigate the influence of breathing pattern on the accuracy of catheter localization. The breathing pattern during the procedure will be monitored and any changes will be related to the accuracy of catheter localization
Measured: during procedure
Influences of procedure duration
To investigate the influence of procedure duration on the accuracy of catheter localization.
Measured: during procedure
Influences of complications during ablation
To investigate the influence of complications during ablation on the accuracy of catheter localization. Complications during the procedure will be registered and categorized.
Measured: during procedure
Influences of patient characteristics
To investigate the influence of patient characteristics on the accuracy of catheter localization. Standard patient characteristics will be noted such as BMI, cardiac output and heartrate to investigate if these characteristics will influence the catheter localization.
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flutter, AtrialStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luuk Hopman, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359678
- Sponsor's protocol ID
- NL85844.015.23
- Acronym
- Northstar
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Accuracy of Catheter Localization With NorthStar Software in Real-Time MRI-Guided Cardiac Ablation
- ClinicalTrials.gov ID
- NCT06359678
- Acronym / sponsor ID
- Northstar / NL85844.015.23
- Conditions
- Flutter, Atrial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 11 Apr 2024 (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 introduction of real-time MRI-guided cardiac ablation therapy, a significant advancement in interventional medicine, necessitates precise catheter tracking for accurate navigation within the complex cardiac anatomy. The introduction of the NorthStar software as an active tracking system holds promise for improving the precision and efficiency of catheter manipulation during these procedures. However, a rigorous evaluation of its accuracy and reliability in a clinical setting is crucial to validate its viability.
The objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during real-time MRI-guided cardiac ablation therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Northstar | Experimental | Device: NorthStarThis is the study group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing a real-time MRI-guided flutter ablation procedure at the Amsterdam UMC.
Key exclusion criteria (2 listed)
- Lack of legal capacity.
- Insufficient proficiency in the Dutch language.
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 |
|---|---|---|
| NorthStarThroughout the real-time MRI-guided ablation procedure, the operator will assess the precision of the NorthStar 3D navigation software. Before commencing the actual ablation, the operator will confirm the alignment of the 3D anatomical shell, generated in NorthStar through specific electrical signals. Post the ablation procedure, a secondary alignment verification will be conducted to detect any potential drift or shift. | Device | Northstar |
Primary outcome
Accuracy of Catheter Localization
Time frame: during procedure
The primary objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during realtime MRI-guided cardiac ablation therapy. At the start of the procedure, the catheters will be manoeuvred to the predefined areas within the right side of the heart based on the specific electrical signals in that area. These locations will be virtually marked within the NorthStar software. The extent to which these markers maintain their spatial coordinates after the ablation procedure, evaluated by obtained electrical signals, will serve as a quantitative measure of the system's accuracy.
4 secondary outcomes
Influences of breathing pattern
Time frame: during procedure
Influences of procedure duration
Time frame: during procedure
Influences of complications during ablation
Time frame: during procedure
Influences of patient characteristics
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NorthStar in people with Flutter, Atrial, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Gotte (020-44440123, mjw.gotte@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Catheter Localization (time frame: during procedure). 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 11 Apr 2024.