orthStar

• Conditions: Atrial Arrhythmia; Atrial flutter; 10007521

• Registration Number: NL-OMON56550
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• 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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to evaluate the accuracy of catheter<br /><br>localization using the NorthStar software during real-time MRI-guided cardiac<br /><br>ablation therapy. At the start of the procedure, the catheters will be<br /><br>manoeuvred to the predefined areas within the right side of the heart based on<br /><br>the specific electrical signals in that area. These locations will be virtually<br /><br>marked within the NorthStar software. The extent to which these markers<br /><br>maintain their spatial coordinates after the ablation procedure, evaluated by<br /><br>obtained electrical signals, will serve as a quantitative measure of the<br /><br>system's accuracy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate the influence of additional factors, such as breathing pattern,<br /><br>procedure duration, complications during ablation, and patient characteristics,<br /><br>on the pre- and post-ablation marker distance. This secondary objective will<br /><br>complement the primary objective of evaluating the accuracy of the NorthStar<br /><br>software.</p><br>