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

Institut Mutualiste Montsouris90 enrolled

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

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 Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Q-MODE : radiofrequency ablation up to 50WPROCEDURE

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 90WPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Mutualiste Montsouris

Paris, Paris, France

RECRUITING

Outcomes

Primary Outcomes

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

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

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

Rate of additional lesions

Rate of additional lesions between all targeted veins and per subject

Time frame: At the end of the ablation procedure

Location of additional lesions

Anatomical location of additional lesions

Time frame: At the end of the ablation procedure

Use of another catheter

Use of another catheter than QDOT in all targeted veins

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

Central Contacts

Naly ANDRIAMBAO

CONTACT

+33156616439 naly.andriambao@imm.fr

Data from ClinicalTrials.gov

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