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Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation

RecruitingNAAges 18 Years - anyAllKlinikum-Fuerth
NCT04678258 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 f

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📋 Eligibility rules (as published)
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
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What it tests

  • HR electroanatomic mapping and MVG catheter ablation
  • Conventional bipolar mapping and linear catheter ablation
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Where

1 site
Klinikum Fuerth
Fürth, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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