Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT06647251
Brief 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
Detailed Description:
Pulmonary vein isolation (PVI) is the main treatment of paroxysmal and persistant atrial fibrillation.
PVI is achieved by point-by-point radiofrequency ablation that creates flexible lesion set within targeted area.
PVI using standard ablation catheter with limited power (50W) have been described in case series with favorable efficacy and safety.
QDOTMicro™ is a radiofrequency ablation catheter that incorporates advanced, high-energy ablation, improved temperature monitoring, optimized irrigation, and higher signal resolution.
QDOT Micro™ provides several options regarding radiofrequency administration :
* Q-MODE : provides high power short duration (HPSD) unitl 50W radiofrequency,
* Q-MODE+ : provides very high power very short duration (vHSPD) until 90W radiofrequency,
* Hybrid Q-MODE/Q-MODE+ : is a combination of two methods. In our experience, stability is a prerequisite for PVI with QDOT Micro™.
Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).
Recently, preliminary animal data argue in favor or reducing the interpoint distance with QDOT™.
To date, there is no study comparing the 3 options of radiofrequency delivery. The aim of our study is to prospectively compare the efficacity and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions.
The same device is used in all three randomisation groups. The difference between the intervention is the intensity of the radiofrequency applied.
Study:
NCT06647251
Study Brief:
Protocol Section:
NCT06647251