Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT06647251
• Lead Sponsor: Institut Mutualiste Montsouris

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Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).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

Study Timeline

• Study First Submitted: 2024-08-27
• Status Verified: 2024-10
• Study Start: 2024-10
• Study First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Primary Completion: 2027-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of primary adverse events related to the ablation procedure	7 days after ablation	Incidence of primary adverse events within 7 days after ablation in the 3 arms
Acute procedural success	At the end of the ablation procedure	Acute procedural success is defined as electrical isolation of all pulmonary veins

Secondary Outcome Measures

Name	Time	Method
Impedance	At the end of the ablation procedure	Impedance
Skin-to-skin time	At the end of the ablation procedure	Skin-to-skin time
Glove-to-glove time	At the end of the ablation procedure	Glove-to-glove time = total procedure time
Mapping time	At the end of the ablation procedure	Mapping time
Total ablation time	At the end of the ablation procedure	Total ablation time
Left vein ablation time	At the end of the ablation procedure	Left vein ablation time
Right vein ablation time	At the end of the ablation procedure	Right vein ablation time
Number of radiofrequency applications	At the end of the ablation procedure	Number of radiofrequency applications
Number of vHPSD radiofrequency applications	At the end of the ablation procedure	Number of vHPSD (very High Power Short Duration) radiofrequency applications
Number of HPSD radiofrequency applications	At the end of the ablation procedure	Number of HPSD (High Power Short Duration) radiofrequency applications
Temperature	At the end of the ablation procedure	Temperature
Power	At the end of the ablation procedure	Power
Contact force	At the end of the ablation procedure	Contact force
Incidence of serious adverse event	within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure	Incidence of serious adverse events
Rate of additional lesions	At the end of the ablation procedure	Rate of additional lesions between all targeted veins and per subject
Location of additional lesions	At the end of the ablation procedure	Anatomical location of additional lesions
Use of another catheter	At the end of the ablation procedure	Use of another catheter than QDOT in all targeted veins
Time spent in operating room	At the end of the ablation procedure	Time spent in operating room

Trial Locations

Locations (1)

Institut Mutualiste Montsouris; 🇫🇷 Paris, France