The Northstar Trial

Not Applicable

Recruiting

• Conditions: Flutter, Atrial
• Interventions: Device: NorthStar

• Registration Number: NCT06359678
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-03-18
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-05
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Lack of legal capacity.
• Insufficient proficiency in the Dutch language.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Northstar	NorthStar	This is the study group

Primary Outcome Measures

Name	Time	Method
Accuracy of Catheter Localization	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.

Secondary Outcome Measures

Name	Time	Method
Influences of breathing pattern	during procedure	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
Influences of complications during ablation	during procedure	To investigate the influence of complications during ablation on the accuracy of catheter localization. Complications during the procedure will be registered and categorized.
Influences of procedure duration	during procedure	To investigate the influence of procedure duration on the accuracy of catheter localization.
Influences of patient characteristics	during procedure	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.

Trial Locations

Locations (1)

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands