To evaluate the accuracy of catheter localization using the NorthStar software during real-time MRI-guided cardiac ablation therapy.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to evaluate the accuracy of catheter
localization using the NorthStar software during real-time 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
To investigate the influence of additional factors, such as breathing pattern,
procedure duration, complications during ablation, and patient characteristics,
on the pre- and post-ablation marker distance. This secondary objective will
complement the primary objective of evaluating the accuracy of the NorthStar
software.
Background 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.
Study objective
To evaluate the accuracy of catheter localization using the NorthStar software
during real-time MRI-guided cardiac ablation therapy.
Study design
The study is a prospective trial involving 20 patients undergoing real-time
MRI-guided flutter ablation procedures at Amsterdam UMC. Patient will be
informed to participate in the study at least two weeks prior to the procedure
by their treating physician and written informed consent will be obtained prior
to the ablation procedure. Markers will be strategically positioned in
NorthStar at key anatomical points (specific anatomical landmarks), guided by
distinct electrical signals. Post-ablation, a re-evaluation of the localization
of the (virtual) markers as displayed by NorthStar will be conducted to assess
the drift of the projected markers, indicating the accuracy of the system. The
ablation procedure will be performed according to current guidelines and
applicable regulations.
Intervention
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. These alignment tests are
anticipated to require only a few minutes.
Study burden and risks
The NorthStar mapping system poses no unique risks in comparison to other
mapping systems commonly employed in clinical settings. Potential risks
associated with the NorthStar mapping system are related to the interventional
devices used with the Mapping system rather than the system itself.
The benefits of this software are not immediately apparent to individual
patients participating in the study, although the improved integrated 3D
visualization provided by NorthStar can contribute to a more streamlined and
efficient treatment process, resulting in a shorter procedural time.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85844.015.23 |
| Other | Pending |