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Recruiting NCT06647251

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

No phase Interventional Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Q-MODE : radiofrequency ablation up to 50W, Q-MODE+ : radiofrequency up to 90W, Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Incidence of primary adverse events related to the ablation procedure [Time frame: 7 days after ablation]
  • Acute procedural success [Time frame: At the end of the ablation procedure]
Secondary outcome measures (12)
  • Incidence of serious adverse event [Time frame: within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure]
  • Rate of additional lesions [Time frame: At the end of the ablation procedure]
  • Location of additional lesions [Time frame: At the end of the ablation procedure]
  • Use of another catheter [Time frame: At the end of the ablation procedure]
  • Time spent in operating room [Time frame: At the end of the ablation procedure]
  • Skin-to-skin time [Time frame: At the end of the ablation procedure]
  • Glove-to-glove time [Time frame: At the end of the ablation procedure]
  • Mapping time [Time frame: At the end of the ablation procedure]
  • Total ablation time [Time frame: At the end of the ablation procedure]
  • Left vein ablation time [Time frame: At the end of the ablation procedure]
  • Right vein ablation time [Time frame: At the end of the ablation procedure]
  • Number of radiofrequency applications [Time frame: At the end of the ablation procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Institut Mutualiste Montsouris — Paris

Identifiers

NCT: NCT06647251 · RYTHMO-03-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗