Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647251
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation AF Ablation
Sponsor:
None
Organization:
None
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:
No
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-MODEQ-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Small series have described encouraging results 85 isolation unpublished data with stabilization tools such as low-volume ventilation or apnea high-rate simualtion Vizigo bi-directional sheath Vizigo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-MODEQ-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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None