Radiation Exposure Clinical Trial
— ZERO MAGICOfficial title:
A Zero Fluoroscopy Maximum Voltage Guided Stepwise Approach Using IntellaMiFi Technology Compared to Linear Ablation of the Cavotricuspid Isthmus for Typical Atrial Flutter: the ZERO MAGIC Trial
Catheter ablation of the cavo-tricuspid isthmus (CTI) is the curative first-line therapy for typical atrial flutter. Currently, two approaches are used in clinical practice. In contrast to the conventional linear ablation approach, the Maximum voltage-guided (MVG) strategy aims to limit ablation to high voltage areas (HVAs) representing the detectable correlate of relevant conducting bundles. Data from registries show that the MVG technique is sufficient to reach comparable clinical outcome with significantly shorter ablation duration when compared to the conventional linear strategy. Despite growing evidence, however, data from properly powered prospective randomized trials are lacking and the linear approach still remains standard. In addition, data on radiation exposure are controversial. As a substrate-based approach, the MVG strategy requires detailed mapping and signal analysis for identification of the individual architecture and exactly targeted energy application. However, the spatial mapping resolution of large tip catheters is limited. The use of the MicroFidelity catheter technology (IntellaMiFi) with high resolution mini-electrodes at the 8 mm catheter tip can be expected to further improve the feasibility of a voltage-guided approach. In addition, the MVG approach theoretically may encompass an increased risk for clinically inapparent reconduction. A prospective study with predefined invasive re-evaluation of persistent CTI block is needed to further evaluate this issue. Objective of this prospective randomized study is evaluate the performance of the micro-sensor technology for zero-fluoroscopy voltage-guided ablation of typical atrial flutter (AFL) compared with a population undergoing conventional linear ablation including a predefined invasive re-evaluation of persistent CTI block in addition to clinical follow-up. The study has been approved by the responsible ethics committee.
Status | Recruiting |
Enrollment | 106 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Typical (CTI dependent) atrial flutter documented in a standard 12 lead surface ECG - Given class I indication for curative CTI ablation according to the current guidelines - Over 18 years old - Given informed consent Exclusion Criteria: - Any contraindication for CTI ablation - Previous CTI ablation - BCB as procedural endpoint not assessable - CTI ablation conducted in association with further ablation procedures - Patients with CIED (e.g. pacemaker, ICD) - Tricuspid valve replacement - Right atrial thrombus - Pregnant or breastfeeding women - Abuse of drugs or alcohol - Age < 18 years - Incompliance to the treatment, e.g. necessary anticoagulation - Expected survival less than one year - Inability to understand the nature and rationale of the study - Inability to take part in the follow up |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Fuerth | Fuerth | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Klinikum-Fuerth | Boston Scientific Corporation, University of Trieste |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative ablation duration | Cumulative ablation duration (total radiofrequency (RF) energy delivery time) in seconds that is needed to achieve sustained complete CTI block (acute procedural efficacy) | during procedure | |
Secondary | Number of RF ablation points, which are necessary to achieve CTI block | Total number of RF ablation points with minimal local energy-delivery of 20 seconds, which are necessary to achieve CTI block | during procedure | |
Secondary | Total amount of RF energy delivery for CTI block | Total amount of RF energy delivery for sustained CTI block (in kilo Joules) | during procedure | |
Secondary | Rate of procedure related adverse events | Safety: The rate of all procedure related adverse events will be documented and analyzed | during procedure | |
Secondary | Fluoroscopy time | The cumulative fluoroscopy duration (in minutes) | during procedure | |
Secondary | Fluoroscopy exposure | Effective dose (ED in µSv) | during procedure | |
Secondary | Number of participants with persistence of CTI block | Number of patients with persistent bidirectional CTI block in electrophysiologic re-evaluation after 3 months. | 3 months follow-up |
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