SMART China, A Multi-center Clinical Registry Study

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

Detailed Description
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The purpose of this study is to assess the effectiveness and safety of the THERMOCOOL® SMARTTOUCH™ catheter in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) undergoing CPVI.

Official Title
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The Effectiveness and Safety in the Treatment of Circumferential Pulmonary Vein Isolation (CPVI) for Symptomatic Paroxysmal Atrial Fibrillation With THERMOCOOL® SMARTTOUCH™ Catheter in China, A Multi-center Clinical Registry Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: THERMOCOOL® SMARTTOUCH™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Failure of at least one antiarrhythmic drug (AAD) for AF (class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD Patients with paroxysmal AF eligible for catheter ablation Patients with symptomatic PAF who have had at least one documented AF episode in the twelve (12) months prior to enrollment. Documentation may include but is not limited to electrocardiogram (ECG), Holter monitor (HM) or transtelephonic monitor (TTM) Able and willing to comply with all pre-, post- and follow-up testing and requirements Be able to sign IRB/EC-approved informed consent form Exclusion Criteria: AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause Previous surgical or catheter ablation for AF Any PCI, cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repart or replacement and presence of a prosthetic valve) within the past 2 months. Any carotid stenting or endarterectomy. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months) AF episodes lasting longer than 7 days or terminated via cardioversion Documented left atrial thrombus on imaging Uncontrolled heart Failure or New York Heart Association (NYHA) class III or IV Myocardial Infarction within the previous 60 days (2 months) Documented thromboembolic event (including TIA) within the past 12 months Rheumatic heart disease Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months) Significant pulmonary disease, (e.g., 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 Active illness or active systemic infection or sepsis Diagnosed atrial myxoma Unstable angina within the past 60 days (2 months) History of blood clotting or bleeding abnormalities Life expectancy less than 365 days (12 months) Hypertrophic obstructive cardiomyopathy Presence of implanted ICD Contraindication to anticoagulation Contraindication to isoproterenol Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation Women who are pregnant and/or breast feeding Presence of a condition that precludes vascular access. Patients presenting contraindications for study catheter(s), as indicated in the respective Instructions For Use 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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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>THERMOCOOL® SMARTTOUCH™ | Device: THERMOCOOL® SMARTTOUCH™<br>* Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)<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 Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes | The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period). | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Where Acute Success Was Achieved | Confirmation of entrance block in all pulmonary veins (PVs) with an isoproterenol intravenous challenge 0.5h post procedure. Exit Block is optional for this study. | 0.5 hours | 
| Average Contact Force Per Pulmonary Vein Ablation Procedure | Contact force (CF) is the force (g) between the device tip and endocardial wall. Two subjects didn't have CF data | 1 day during procedure | 
| Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure | Percentage of subjects with PV reconnection after the first ablation | 1 day during procedure | 
| Procedure Time, Ablation Time and Fluoroscopy Time | Procedure Time, Ablation Time and Fluoroscopy Time in minutes | 1 day during procedure | 

 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, Catheter ablation