Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation
Recruiting · NCT06647251 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut Mutualiste Montsouris
View the official record on ClinicalTrials.gov →Interventions studied
Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior partQ-MODE : radiofrequency ablation up to 50WQ-MODE+ : radiofrequency up to 90W
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Institut Mutualiste Montsouris - Paris, Paris, France