RecruitingNot ApplicableNCT06647251

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

Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal AF Ablation: a Prospective Study

Sponsor

Institut Mutualiste Montsouris

Enrollment

90 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria7

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

Interventions

PROCEDUREQ-MODE : radiofrequency ablation up to 50W

The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care. For patient randomized in this arm, the device is set to Q-MODE option: the intensity of radiofrequency to isolate the pulmonary vein is limited to 50W.

PROCEDUREQ-MODE+ : radiofrequency up to 90W

The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care. For patient randomized in this arm, the device is set to Q-MODE+ option: the intensity of radiofrequency to isolate the pulmonary vein is limited to 90W.

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

The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care. For patient randomized in this arm, the device is set to "Q-MODE/Q-MODE+" option: the intensity of radiofrequency delivered to isolate the pulmonary vein is limited to 50W in the anterior part and to 90W in the posterior part.