High Power vs Standard Power RF Ablation of Atrial Fibrillation in Conscious Patients

Study Overview
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Brief Summary
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High RF energy ablation of atrial fibrillation is fast, safe, less painful and effective procedure.

Detailed Description
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Atrial fibrillation (AF) ablation is the most commonly performed radiofrequency (RF) ablation and is usually associated with a long procedural time and sensation of pain in conscious patients. Prolonged radiation exposure during the procedure puts the patient and the operator at risk of malignancy and genetic abnormalities. Complications such as asymptomatic cerebral lesions, tamponade, perforation, and also arrhythmia recurrence were associated with longer ablation time. High-power, shorter-duration radiofrequency ablation (HPSDRFA) appears to be a novel concept for atrial fibrillation (AF) but there are scarce data in conscious patients. The lesion side index (LSI) value has been associated with durability of pulmonary vein isolation (PVI) lesions. We hypothesised that HPSDRFA applications based on the lesion side index (LSI; its has been associated with durability of pulmonary vein isolation (PVI) lesions) which were not inferior to standard approach regarding safety and effectiveness with shorten procedure time and being less painful for a patient.

Official Title
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HPvSP-AF Trail: Is High RF Energy Ablation of Atrial Fibrillation Fast, Safe, Less Painful and Effective - a Propensity Score Matched Analysis of 30/25W, 40W and 50W RF Energy Settings

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: RF ablation of atrial fibrillation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic patients with non-valvular AF, aged:18-85, first procedure in left atrium, exclusion of thrombus in left atrium and left atrium appendage, left ventricle ejection fraction >55% Exclusion Criteria: age below 18 or above 85 years, left ventricle ejection fraction<55%, previous procedure in left atrium, valvular AF

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard RF<br>ablation with RF power of 30 Watts (30W) and with 25 Watts (25W) on posterior wall | Other: RF ablation of atrial fibrillation<br>* Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation<br>|
| High RF 40W (40 Watts)<br>ablation with RF power of 40 watts (40W) | Other: RF ablation of atrial fibrillation<br>* Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation<br>|
| High RF 50W (50 Watts)<br>ablation with RF power of 50 watts (50W) | Other: RF ablation of atrial fibrillation<br>* Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time: | Total procedure time (needle to needle time). | procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left atrial dwelling time | time of left atrium instrumentation | transeptal access to removal of a catheter and a sheath | 
| Voltage mapping time | time needed to perform 3D electroanatomical map and high density voltage mapping of left atrium. | procedure | 
| Total RF time | time of all performed radiofrequency (RF) applications | procedure | 
| Total number of RF applications | number of all RF applications performed during a procedure | procedure | 
| X-Ray time | the total time of fluoroscopy | procedure | 
| Complications | both procedure-related complications and all complications in 12 moths follow-up as follows: Cardiac tamponade/perforation [yes/no], Stroke/TIA (Transient ischemic attack) [yes/no], Oesophageal injury (perforation/fistula) [yes/no], Death (procedural related, one year follow up) [yes/no], Stem pops [yes/no], Catheter char [yes/no], Phrenic nerve paralysis [yes/no], PV stenosis requiring intervention [yes/no], Gastrointestinal bleeding or gastrointestinal complaints [yes/no], Need for periprocedural pacemaker implantation [yes/no], Vascular access complication which required intervention [yes/no], Vascular access complication which not required intervention [yes/no], | 12 months | 
| Number of stopped RF applications as a result of pain complained by a patient | the surrogate for assessment of the painfulness of the procedure | procedure | 
| Follow-up-30s | absence any arrhythmia recurrence (AR) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL) lasting longer than 30 second | procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation ablation, high power radiofrequency ablation