An interventional study of NorthStar in Flutter, Atrial, sponsored by Amsterdam UMC, location VUmc. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Diagnostic
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.
223 studies on the registry are indexed under Atrial Flutter; 51 are open to participants now.
This study's planned enrollment of 20 is below the median of 150 across 155 interventional studies indexed under Atrial Flutter.
Browse Atrial Flutter studies →Amsterdam UMC, location VUmc is the lead sponsor of 305 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This is the study group
Device: NorthStar
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.
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.
Time frame: during procedure
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
Time frame: during procedure
Influences of procedure duration
To investigate the influence of procedure duration on the accuracy of catheter localization.
Time frame: 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.
Time frame: 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.
Time frame: during procedure
Started Jan 2024 (actual). Primary completion is estimated for Jan 2025, 12 months after the start.
Of 55 interventional studies with no phase under Atrial Flutter, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 63. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amsterdam UMC, location VUmc →