The Northstar Trial

NCT06359678 | Recruiting

• 1 other identifier: NL85844.015.23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Flutter, Atrial

Outcome Measures

Primary Outcomes (1)

• Accuracy of Catheter Localization

  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.

  during procedure

Secondary Outcomes (4)

• Influences of breathing pattern

  during procedure

• Influences of procedure duration

  during procedure

• Influences of complications during ablation

  during procedure

• Influences of patient characteristics

  during procedure

Study Arms (1)

Northstar

EXPERIMENTAL

This is the study group

Device: NorthStar

Interventions

NorthStar DEVICE

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.

Northstar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marco Gotte

CONTACT

020-44440123; mjw.gotte@amsterdamumc.nl

Luuk Hopman

CONTACT

020-44441405; l.hopman@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 11, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

NL (1)