NCT06647251

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Institut Mutualiste Montsouris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Q-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.
PROCEDURE	Q-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.
PROCEDURE	Hybride 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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2024-10-17
• Last updated: 2024-10-17

Locations

1 site across 1 country: France