An interventional study of Q-MODE : radiofrequency ablation up to 50W and Q-MODE+ : radiofrequency up to 90W in Atrial Fibrillation, sponsored by Institut Mutualiste Montsouris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Institut Mutualiste Montsouris · Not applicable, Interventional, and Treatment
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
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 :
Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).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.
Exclusion Criteria:
Radiofrequency ablation with High Power - Short Duration (HPSD) up to 50W.
Procedure: Q-MODE : radiofrequency ablation up to 50W
Radiofrequency ablation with High Power - Short Duration (HPSD) up to 90W.
Procedure: Q-MODE+ : radiofrequency up to 90W
A combination of the two ablation methods.
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 option: the intensity of radiofrequency to isolate the pulmonary vein is limited 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 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/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.
Incidence of primary adverse events related to the ablation procedure
Incidence of primary adverse events within 7 days after ablation in the 3 arms
Time frame: 7 days after ablation
Acute procedural success
Acute procedural success is defined as electrical isolation of all pulmonary veins
Time frame: At the end of the ablation procedure
Incidence of serious adverse event
Incidence of serious adverse events
Time frame: within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure
Rate of additional lesions
Rate of additional lesions between all targeted veins and per subject
Time frame: At the end of the ablation procedure
Location of additional lesions
Anatomical location of additional lesions
Time frame: At the end of the ablation procedure
Use of another catheter
Use of another catheter than QDOT in all targeted veins
Time frame: At the end of the ablation procedure
Time spent in operating room
Time spent in operating room
Time frame: At the end of the ablation procedure
Skin-to-skin time
Skin-to-skin time
Time frame: At the end of the ablation procedure
Glove-to-glove time
Glove-to-glove time = total procedure time
Time frame: At the end of the ablation procedure
Mapping time
Mapping time
Time frame: At the end of the ablation procedure
Total ablation time
Total ablation time
Time frame: At the end of the ablation procedure
Left vein ablation time
Left vein ablation time
Time frame: At the end of the ablation procedure
Right vein ablation time
Right vein ablation time
Time frame: At the end of the ablation procedure
Number of radiofrequency applications
Number of radiofrequency applications
Time frame: At the end of the ablation procedure
Number of vHPSD radiofrequency applications
Number of vHPSD (very High Power Short Duration) radiofrequency applications
Time frame: At the end of the ablation procedure
Number of HPSD radiofrequency applications
Number of HPSD (High Power Short Duration) radiofrequency applications
Time frame: At the end of the ablation procedure
Temperature
Temperature
Time frame: At the end of the ablation procedure
Power
Power
Time frame: At the end of the ablation procedure
Contact force
Contact force
Time frame: At the end of the ablation procedure
Impedance
Impedance
Time frame: At the end of the ablation procedure
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut Mutualiste Montsouris