SMART-SF Radiofrequency Ablation Safety Study

Study Overview
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Brief Summary
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This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).

Detailed Description
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The purpose of this study is to demonstrate the safety of the study device in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.

Official Title
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Prospective Safety Assessment of the THERMOCOOL® SMARTTOUCH® SF Family of Contact Force Sensing Catheters for the Radiofrequency Ablation Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: THERMOCOOL® SMARTTOUCH® (RF ablation treatment)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic paroxysmal atrial fibrillation (AF) who have had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment and a physician's note indicating recurrent, self-terminating AF. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip Failed at least one antiarrhythmic drug (AAD) (class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerable to the AAD Age 18 years or older Exclusion Criteria: Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause Previous surgical or catheter ablation for atrial fibrillation Amiodarone at any time during the past 3 months Any percutaneous coronary intervention (PCI), cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) within the past 2 months Any carotid stenting or endarterectomy Coronary artery bypass graft (CABG) surgery within the past 6 months AF episodes lasting >7 days Documented left atrial (LA) thrombus on imaging LA size >50 mm Left ventricular ejection fraction (LVEF) < 40% Contraindication to anticoagulation (heparin or warfarin) History of blood clotting or bleeding abnormalities MI within the past 2 months Documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months Rheumatic Heart Disease Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV Awaiting cardiac transplantation or other cardiac surgery within the next 12 months Unstable angina Acute illness or active systemic infection or sepsis Diagnosed atrial myxoma Presence of implanted implantable cardioverter defibrillator (ICD) Significant pulmonary disease, (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) Enrollment in an investigational study evaluating another device, biologic, or drug Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter Presence of a condition that precludes vascular access Life expectancy or other disease processes likely to limit survival to less than 6 months

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device) | Device: THERMOCOOL® SMARTTOUCH® (RF ablation treatment)<br>* Radiofrequency Ablation Treatment<br>* Other names: Pulmonary vein isolation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Early Onset Primary Adverse Events | Early onset is defined as within 7 days of the atrial fibrillation (AF) ablation procedure. Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade / Perforation, Pneumothorax, Major Vascular Access Complications / Bleeding, Pulmonary edema (Respiratory Insufficiency), and Heart block. | Seven days post ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Non-Primary Serious Adverse Events (SAEs) | This secondary safety endpoint includes non-primary serious adverse events (SAEs) within 7 days post-procedure and serious adverse events from 8 days to 30 days post-procedure | Up to 30 days post Procedure | 
| Percentage of Participants With Acute Success | Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV). | End of procedure | 
| Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL) | The freedom from documented AF/AT/AFL based on electrocardiographic data | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interventional, Radiofrequency ablation, Paroxysmal Atrial Fibrillation