Clinical trial NCT06647251: Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation
Official title: Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal AF Ablation: a Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).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.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 or over
* 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:

* History of atrial fibrillation ablation (surgery or catheter)
* 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

Primary outcomes:
measure: Incidence of primary adverse events related to the ablation procedure
timeFrame: 7 days after ablation
measure: Acute procedural success
timeFrame: At the end of the ablation procedure
Secondary outcomes:
measure: Incidence of serious adverse event
timeFrame: within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure
measure: Rate of additional lesions
timeFrame: At the end of the ablation procedure
measure: Location of additional lesions
timeFrame: At the end of the ablation procedure
measure: Use of another catheter
timeFrame: At the end of the ablation procedure
measure: Time spent in operating room
timeFrame: At the end of the ablation procedure
measure: Skin-to-skin time
timeFrame: At the end of the ablation procedure
measure: Glove-to-glove time
timeFrame: At the end of the ablation procedure
measure: Mapping time
timeFrame: At the end of the ablation procedure
measure: Total ablation time
timeFrame: At the end of the ablation procedure
measure: Left vein ablation time
timeFrame: At the end of the ablation procedure
measure: Right vein ablation time
timeFrame: At the end of the ablation procedure
measure: Number of radiofrequency applications
timeFrame: At the end of the ablation procedure
measure: Number of vHPSD radiofrequency applications
timeFrame: At the end of the ablation procedure
measure: Number of HPSD radiofrequency applications
timeFrame: At the end of the ablation procedure
measure: Temperature
timeFrame: At the end of the ablation procedure
measure: Power
timeFrame: At the end of the ablation procedure
measure: Contact force
timeFrame: At the end of the ablation procedure
measure: Impedance
timeFrame: At the end of the ablation procedure
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Frédéric SEBAG
role: PRINCIPAL_INVESTIGATOR
References: