Efficacy of Anterior Wall PVI With QDOT Catheter - Intraprocedural Comparison Between vHPSD and HPSD Ablation.

Study Overview
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Brief Summary
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This study is a prospective, randomized controlled study to evaluate intraprocedural efficacy of anterior aspects of pulmonary veins insolation between very High Power Short Duration (vHPSD) and High Power Short Duration (HPSD) in patient with paroxysmal or persistent Atrial Fibrillation.

Detailed Description
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This study is a dual-center, prospective, randomized controlled study to evaluate intraprocedural efficacy of anterior aspects of pulmonary veins isolation between very High Power Short Duration (vHPSD) and High Power Short Duration (HPSD) in patient with paroxysmal or persistent atrial fibrillation (AF). Catheter ablation of atrial fibrillation with circumferential pulmonary vein isolation is an well-established method of treatment, particularly in symptomatic patients with atrial fibrillation (AF) who are ineffective or refractory to pharmacological treatment. Recurrence of pulmonary veins conduction is considered as a risk factor for future recurrence of AF. This may be partly related to the incomplete scar formation during the index ablation procedure. Constant technological progress (i.e. ablation catheters with contact force) has led to greater efficiency in obtaining complete isolation of pulmonary veins, achieving nearly 90% success rate in 12-month follow-up paroxysmal AF (CLOSE protocol). The duration of the RF application depends on the ablation index (AI), which proves that the energy has been effectively delivered to the myocardium. Currently, AI values are considered representative of RF power up to 50W. When energy above 50 W was used, the scar size was shown to be smaller than when the same AI value was used but with higher power. The safety and efficacy of novel ablation catheter QDOT (Biosense Webster, Irvine, CA, USA), that allows to deliver very high and high-power short-duration ablation, was already proven in clinical trials (QDOT FAST, Q-FFICIENCY). The benefits from using very high power short-duration ablation include: 1) shortening the duration of the procedure, 2) reducing the volume of fluids administered through the ablation electrode during RF application, which may be important in patients with heart and kidney failure, 3) reducing the frequency of collateral damages to surrounding structures of the heart (e.g. oesophagus). One of the differences related to the biophysics of RF applications between high and low energy is the range of penetration into the muscle tissue, which could impact on effectiveness of ablation. It was shown that lesions performed with vHPSD were smaller (up to 2,9 mm deep) compared to HPSD or conventional power with target AI. It is attractive for posterior wall of left atrium and can reduce peri-procedural complications. However vHPSD could be insufficient in some regions of anterior wall of the left atrium, which thickness may vary from 1 to 4 mm. Our research hypothesis is that integrated approach with different energies depending on the left atrium location is safe and lead to better efficacy than use of only vHPSD ablation in terms of first pass isolation.

Official Title
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Optimization of PVI Strategy Using QDOT Catheter. What is the Proper Energy Level for Anterior Wall of Pulmonary Veins- Intraprocedural Efficacy Comparison Between HSPD and vHPSD (The A-Q-RATE POWER Trial)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: QMODE +
* Device: QMODE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for their first AF ablation procedure Written informed consent Paroxysmal or persistent AF Age > 18 Exclusion Criteria: previous ablation procedure with pulmonary vein isolation lack of written informed consent pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Very high-power short-duration<br>A QDOT® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Irvine, CA, USA) will be used. In this group vHPSD (90W) will be performed. This power settings will be used for all ablation points. | Device: QMODE +<br>* Atrial fibrillation radiofrequency ablation of the anterior and posterior wall with 90W (vHPSD)<br>|
| Active Comparator: High-power short-duration<br>A QDOT® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Irvine, CA, USA) will be used. Ablation of the anterior aspect of the pulmonary veins will be performed with high-power short-duration (50 W) with target ablation index =550. Ablation of the posterior wall of the pulmonary veins will be performed with vHPSD (90W). | Device: QMODE<br>* Atrial fibrillation radiofrequency ablation of the anterior wall with 50W (HPSD). Ablation of the posterior wall with 90 W (vHPSD)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute procedural success | First pass isolation of anterior wall of pulmonary veins. | During ablation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of additional RF application needed to obtain pulmonary vein isolation | Number of additional RF application needed to obtain pulmonary vein isolation | during ablation | 
| percentage of pulmonary vein pairs isolated with first encirclement | percentage of pulmonary vein pairs isolated with first encirclement | during ablation | 
| Total procedure duration | skin to skin procedure duration | during ablation | 
| Incidence of peri-procedural complications | Incidence of peri-procedural complications such as cardiac tamponade, stroke, pericardial effusion > 1 cm, TIA, vascular complications. | during ablation | 
| Fluoroscopy time | fluoroscopy time | during ablation | 
| Change of heart rhythm after right pulmonary veins isolation | Change of heart rhythm after right pulmonary veins isolation | during ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, QDOT, very high power short-duration, pulmonary vein isolation, left atrial wall thickness, catheter ablation