Flutter, Atrial Clinical Trial
— NorthstarOfficial title:
Assessing the Accuracy of Catheter Localization With NorthStar Software in Real-Time MRI-Guided Cardiac Ablation
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | January 1, 2025 |
| Est. primary completion date | January 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Amsterdam UMC | Amsterdam |
| Lead Sponsor | Collaborator |
|---|---|
| Amsterdam UMC, location VUmc |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Influences of breathing pattern | 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 | during procedure | |
| Secondary | Influences of procedure duration | To investigate the influence of procedure duration on the accuracy of catheter localization. | during procedure | |
| Secondary | Influences of complications during ablation | To investigate the influence of complications during ablation on the accuracy of catheter localization. Complications during the procedure will be registered and categorized. | during procedure | |
| Secondary | Influences of patient characteristics | 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. | during procedure |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03250871 -
Hypnosis in Interventional Electrophysiology
|
N/A |