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

ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Mutualiste Montsouris

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Q-MODE : radiofrequency ablation up to 50W

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Q-MODEActive comparator 1 intervention
Group B: Q-MODE+Active comparator 1 intervention
Group C: Hybride Q-MODE/Q-MODE+Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of primary adverse events related to the ablation procedure

Incidence of primary adverse events within 7 days after ablation in the 3 arms

Time frame
7 days after ablation
2

Acute procedural success

Acute procedural success is defined as electrical isolation of all pulmonary veins

Time frame
At the end of the ablation procedure

Secondary outcomes

1

Incidence of serious adverse event

Incidence of serious adverse events

Time frame
within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure
2

Rate of additional lesions

Rate of additional lesions between all targeted veins and per subject

Time frame
At the end of the ablation procedure
3

Location of additional lesions

Anatomical location of additional lesions

Time frame
At the end of the ablation procedure
4

Use of another catheter

Use of another catheter than QDOT in all targeted veins

Time frame
At the end of the ablation procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Mutualiste Montsouris

Lead sponsor

Source ClinicalTrials.gov
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