NCT06359678

The Northstar Trial

Assessing the Accuracy of Catheter Localization With NorthStar Software in Real-Time MRI-Guided Cardiac Ablation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-04-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: Netherlands