Comparing three methods of radiofrequency delivery for treating atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the efficacy and safety of three different radiofrequency delivery methods using the QDOT Micro™ catheter for patients with paroxysmal atrial fibrillation. The methods include Q-MODE, which delivers high power at a short duration, Q-MODE+ for very high power at very short duration, and a hybrid approach combining both methods. The study will systematically use catheter stabilization tools to ensure effective pulmonary vein isolation. By evaluating these methods, the study seeks to determine the best approach for achieving optimal treatment outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Institut Mutualiste Montsouris
  Paris, Paris, France Recruiting

Study contacts

• Principal investigator: Frédéric SEBAG — Institut Mutualiste Montsouris
• Study coordinator: Naly ANDRIAMBAO
• Email: naly.andriambao@imm.fr
• Phone: +33156616439

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.