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Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation

RecruitingNAAges 18 Years - anyAllInstitut Mutualiste Montsouris
NCT06647251 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pulmonary vein isolation is the main treatment of paroxysmal and persistent atrial fibrillation. The aim of our study is to prospectively compare the efficacy and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient aged 18 or over * First atrial fibrillation ablation * Paroxysmal atrial fibillation defined as atrial fibrillation lasting less than 48 hours * Early atrial fibrillation defined as atrial fibrillation lastiing between 7 days and 3 months * At least one episode of atrial fibrillation in the year preceding study entry * Patient affiliated to a health insurance Exclusion Criteria: * History of atrial fibrillation ablation (surgery or catheter) * Documented left atrial thrombus * Left atrial (LA) diameter \> 60mm / LA area \> 35cm2 / Left atrial volulme index (LAVI) \> 45ml/m2 * N/STEMI replacement or angioplasty or valve within 3 months prior to registration * Any contraindication mentioned in the instructions for use of the QDOT MICRO™ bidirectional navigation catheter * Patient unable to understand study information * Patient deprived of liberty by judicial or administrative decision
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What it tests

  • Q-MODE : radiofrequency ablation up to 50W
  • Q-MODE+ : radiofrequency up to 90W
  • Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part
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Where

1 site
Institut Mutualiste Montsouris
Paris, France
🤝 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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