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

Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal AF Ablation: a Prospective Study

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

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Q-MODE : radiofrequency ablation up to 50W; Procedure: Q-MODE+ : radiofrequency up to 90W; Procedure: Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part

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Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naly ANDRIAMBAO; Phone Number: +33156616439; Email: naly.andriambao@imm.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Institut Mutualiste Montsouris
    • Contact: Frederic SEBAG; Phone Number: +33156616263; Email: frederic.sebag@imm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Q-MODE; Radiofrequency ablation with High Power - Short Duration (HPSD) up to 50W.	Procedure: 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.
Active Comparator: Q-MODE+; Radiofrequency ablation with High Power - Short Duration (HPSD) up to 90W.	Procedure: 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.
Active Comparator: Hybride Q-MODE/Q-MODE+; 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/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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Institut Mutualiste Montsouris
• Investigators: Principal Investigator: Frédéric SEBAG, Institut Mutualiste Montsouris

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: RYTHMO-03-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes