RecruitingNot ApplicableNCT04678258

Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation

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


Sponsor

Klinikum-Fuerth

Enrollment

106 participants

Start Date

Nov 30, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria14

  • 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

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Interventions

PROCEDUREHR electroanatomic mapping and MVG catheter ablation

High resolution CTI mapping using the mini-electrodes at the 8 mm catheter tip followed by voltage guided ablation

PROCEDUREConventional bipolar mapping and linear catheter ablation

Bipolar mapping and conventional anatomic linear catheter ablation


Locations(1)

Klinikum Fuerth

Fürth, Bavaria, Germany

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NCT04678258


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