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NorthStar

NorthStar - NorthStar

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56550
Enrollment
20
Registered
2024-02-08
Start date
2024-04-04
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Arrhythmia Atrial flutter

Interventions

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 confi

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients undergoing a real-time MRI-guided flutter ablation procedure at the Amsterdam UMC.

Exclusion criteria

Exclusion criteria: Lack of legal capacity. Insufficient proficiency in the Dutch language.

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during real-time 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.

Secondary

MeasureTime frame
To investigate the influence of additional factors, such as breathing pattern, procedure duration, complications during ablation, and patient characteristics, on the pre- and post-ablation marker distance. This secondary objective will complement the primary objective of evaluating the accuracy of the NorthStar software.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 25, 2026