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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Mutualiste Montsouris

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators