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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Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q-MODE | Active Comparator | Radiofrequency ablation with High Power - Short Duration (HPSD) up to 50W. |
|
| Q-MODE+ | Active Comparator | Radiofrequency ablation with High Power - Short Duration (HPSD) up to 90W. |
|
| Hybride Q-MODE/Q-MODE+ | Active Comparator | A combination of the two ablation methods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q-MODE : radiofrequency ablation up to 50W | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of primary adverse events related to the ablation procedure | Incidence of primary adverse events within 7 days after ablation in the 3 arms | 7 days after ablation |
| Acute procedural success | Acute procedural success is defined as electrical isolation of all pulmonary veins | At the end of the ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse event | Incidence of serious adverse events | within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure |
| Rate of additional lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naly ANDRIAMBAO | Contact | +33156616439 | naly.andriambao@imm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Frédéric SEBAG | Institut Mutualiste Montsouris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Mutualiste Montsouris | Recruiting | Paris | Paris | 75014 | France |
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Patients will be randomly assigned to one of the following arms: Q-MODE, Q-MODE+, hybride Q-MODE/Q-MODE+.
The number of patients in each arm is the same.
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|
| Q-MODE+ : radiofrequency up to 90W | Procedure | 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. |
|
| Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part | Procedure | 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. |
|
Rate of additional lesions between all targeted veins and per subject
| At the end of the ablation procedure |
| Location of additional lesions | Anatomical location of additional lesions | At the end of the ablation procedure |
| Use of another catheter | Use of another catheter than QDOT in all targeted veins | At the end of the ablation procedure |
| Time spent in operating room | Time spent in operating room | At the end of the ablation procedure |
| Skin-to-skin time | Skin-to-skin time | At the end of the ablation procedure |
| Glove-to-glove time | Glove-to-glove time = total procedure time | At the end of the ablation procedure |
| Mapping time | Mapping time | At the end of the ablation procedure |
| Total ablation time | Total ablation time | At the end of the ablation procedure |
| Left vein ablation time | Left vein ablation time | At the end of the ablation procedure |
| Right vein ablation time | Right vein ablation time | At the end of the ablation procedure |
| Number of radiofrequency applications | Number of radiofrequency applications | At the end of the ablation procedure |
| Number of vHPSD radiofrequency applications | Number of vHPSD (very High Power Short Duration) radiofrequency applications | At the end of the ablation procedure |
| Number of HPSD radiofrequency applications | Number of HPSD (High Power Short Duration) radiofrequency applications | At the end of the ablation procedure |
| Temperature | Temperature | At the end of the ablation procedure |
| Power | Power | At the end of the ablation procedure |
| Contact force | Contact force | At the end of the ablation procedure |
| Impedance | Impedance | At the end of the ablation procedure |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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