Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.

Study Overview
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Brief Summary
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Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients with paroxysmal atrial fibrillation (PAF) [1]. However, the incidence of atrial fibrillation (AF) recurrence remains high [2], mostly due to pulmonary vein (PV) reconnection [1], emphasizing the formation of transmural lesions to achieve complete conduction block along the ablation lines [3]. Previous studies have shown that elimination of the negative component of the unipolar electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The persistence of such a negative component consistently corresponds to non-trans mural lesions [4].

Detailed Description
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Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients with paroxysmal atrial fibrillation (PAF) [1]. However, the incidence of atrial fibrillation (AF) recurrence remains high [2], mostly due to pulmonary vein (PV) reconnection [1], emphasizing the formation of transmural lesions to achieve complete conduction block along the ablation lines [3]. Previous studies have shown that elimination of the negative component of the unipolar electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The persistence of such a negative component consistently corresponds to non-trans mural lesions [4]. The high-power short duration (HPSD) RF application applies to all RF energies delivered at more than 40 W [5]. Higher the power more is the resistive heating causing wider tissue injury [5]. The lesion size with HPSD is larger in width but lesser in depth compared to lower powers with longer duration [5]. In contrast, RF applications of lower power and longer duration result in larger dissipation of RF energies deep into the tissues due to conductive heating causing tissue destruction at greater depths [6]. Hence, there is a risk of collateral tissue damage [5]. HPSD ablation has been advocated as a means to minimize the risk of collateral organ damage as the lesions are smaller in depth. However, Maintaining a high power for a constant duration in the absence of a guide may not be the right strategy [5]. Unipolar waveform modification by complete elimination of the negative component may serve as a guide for HPSD ablation [5].

Official Title
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Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.

Conditions
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Atrial Fibrillation Paroxysmal

Intervention / Treatment
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* Procedure: high power application
* Procedure: Standard power application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paroxysmal atrial fibrillation Exclusion Criteria: Age< 18 or > 80 years old, Atrium (LA) diameter > 50 mm, The presence of a mechanical mitral valve prosthesis, Left ventricular ejection fraction < 40%, Abnormal thyroid function, Contraindication to anticoagulant therapy, Current malignancy, Prior catheter or surgical AF ablation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard power application<br> | Procedure: Standard power application<br>* Standard power application<br>|
| Active Comparator: High power application<br> | Procedure: high power application<br>* Radiofrequency delivery was performed in a point-by point fashion and continuously (an inter-lesion distance of 6 mm) with 50 W and 70 W and the ablation time for each point is limited to 7s and repeated if needed till the Unipolar signal modification turn to complete positive R wave.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablation success at 6-month after the index procedure | Ablation success is defined as no recurrence with no anti-arrhythmic drugs by taking history of symptoms from the patient and by Holter 48 Hours. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation ablation - unipolar signal modification