Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 12:40 PM
Study NCT ID:
NCT06647251
Status:
RECRUITING
Last Update Posted:
2024-10-17
First Post:
2024-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation
Sponsor:
Institut Mutualiste Montsouris
Organization:
Study Overview
Official Title:
Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal AF Ablation: a Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QDOT
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
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Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: