The Northstar Trial

Amsterdam UMC, location VUmc

Status: Enrolling

Conditions: Flutter, Atrial

Treatments: Device: NorthStar

Study type: Interventional

Funder types: Other

Identifiers

NCT06359678

NL85844.015.23

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Northstar

Experimental group

Description:

This is the study group

Treatment:

Device: NorthStar