THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study

Study Overview
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Brief Summary
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A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI). Prospectively or retrospectively record 150 eligible subjects since 1st Jan 2019 to evaluate effectiveness and safety of STSF with AI.

Detailed Description
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The purpose of this study is to measure the long term effectiveness，clinical benefit, and safety outcomes of catheter ablation with STSF and AI for paroxysmal atrial fibrillation (PAF) subjects up to 12-month follow-up. Subject:Up to 150 PAF subjects will be included in the study data, representing all consecutive subjects having catheter ablation with AI guiding STSF and for the treatment of PAF at the site. Primary endpoint: The primary endpoint is freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure. Secondary endpoint : Acute success at 0.5hour CPVI (i.e. entrance block achieved in all veins, verified via an isoproterenol intravenous challenge) Numbers of reconnected pulmonary veins (PV), with number and location of any gaps Procedural efficiency measures（e.g. mapping time, ablation time, total procedure time, and fluid volume delivered via catheter. AI values Inter-Tag distances Adverse events (Complications related to device or procedure) Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year Clinical Study Sites: Shanghai General Hospital Study Duration: 18-month enrollment period, with follow-up at 3, 6 and 12 months after ablation, with a blanking period defined as the period within 90 days after the ablation.

Official Title
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Clinical Benefit, Long Term Effectiveness, and Safety Outcome of Paroxysmal Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index

Conditions
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Paroxysmal Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Patient has PAF eligible for AI-guided catheter ablation with an STSF catheter per standard of care assessment Able and willing to comply with all pre-, post- and follow-up testing and requirements Able to sign EC-approved informed consent form Exclusion Criteria: AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause Patient has AF episodes lasting longer than 7 days History of heart surgery, or any previous ablation for AF Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months Documented left atrial thrombus on imaging New York Heart Association (NYHA) class III or IV heart failure Hypertrophic obstructive cardiomyopathy Presence of implantable cardioverter defibrillator (ICD) Contraindication to isoproterenol Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator Women who are pregnant and/or breast feeding Enrollment in an investigational study evaluating another device, biologic, or drug

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure. | Atrial tachyarrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period. | 91-365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of acute success at 0.5hour CPVI | Entrance block rate achieved by all pulmonary veins after 0.5hour waiting time and isoproterenol challenge after CPVI | 91-365 days | 
| Numbers of reconnected pulmonary veins (PV), with number and location of any gaps | Numbers of pulmonary veins recovered after 0.5hour waiting time and isoproterenol challenge after CPVI, and the location of recovery and number are also recorded | 91-365 days | 
| Mapping time | Procedural efficiency measures | 91-365 days | 
| Contact force in grams | Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation | 91-365 days | 
| Rate of adverse events occurred | Complications related to device or procedure | 91-365 days | 
| Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year | Rate of patients who are back to hospital and got hospitalized due to AF/AT/AFL recurrence or procedure-related reasons during 91 to 365 days after procedure | 91-365 days | 
| Ablation time | Procedural efficiency measures | 91-365 days | 
| Total procedure time | Procedural efficiency measures | 91-365 days | 
| Fluid volume delivered via catheter | Procedural efficiency measures | 91-365 days | 
| Ablation times in seconds | Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation | 91-365 days | 
| Inter Tag in micrometers | Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation | 91-365 days | 
| RF ablation and fluoroscopy times in seconds | Ablation Index values physiological parameter of the Carto 3 which is background data generated during operation | 91-365 days |