Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation
NCT ID: NCT06647251
Last Updated: 2024-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2024-10-31
2028-10-31
Brief Summary
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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
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Detailed Description
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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Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).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
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Study Design
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RANDOMIZED
PARALLEL
The number of patients in each arm is the same.
TREATMENT
NONE
Study Groups
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Q-MODE
Radiofrequency ablation with High Power - Short Duration (HPSD) up to 50W.
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.
Q-MODE+
Radiofrequency ablation with High Power - Short Duration (HPSD) up to 90W.
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.
Hybride Q-MODE/Q-MODE+
A combination of the two ablation methods.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* First atrial fibrillation ablation
* Paroxysmal atrial fibillation defined as atrial fibrillation lasting less than 48 hours
* Early atrial fibrillation defined as atrial fibrillation lastiing between 7 days and 3 months
* At least one episode of atrial fibrillation in the year preceding study entry
* Patient affiliated to a health insurance
Exclusion Criteria
* Documented left atrial thrombus
* Left atrial (LA) diameter \> 60mm / LA area \> 35cm2 / Left atrial volulme index (LAVI) \> 45ml/m2
* N/STEMI replacement or angioplasty or valve within 3 months prior to registration
* Any contraindication mentioned in the instructions for use of the QDOT MICRO™ bidirectional navigation catheter
* Patient unable to understand study information
* Patient deprived of liberty by judicial or administrative decision
18 Years
ALL
No
Sponsors
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Institut Mutualiste Montsouris
OTHER
Responsible Party
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Principal Investigators
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Frédéric SEBAG
Role: PRINCIPAL_INVESTIGATOR
Institut Mutualiste Montsouris
Locations
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Institut Mutualiste Montsouris
Paris, Paris, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RYTHMO-03-2024
Identifier Type: -
Identifier Source: org_study_id
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