Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.

Detailed Description
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The STELLAR study is a pivotal, prospective, multicenter, single-arm, clinical evaluation of the Multi-Electrode RF Balloon catheter. The study will evaluate the safety and effectiveness of the Multi-Electrode RF Balloon catheter used for ablation in patients with paroxysmal atrial fibrillation (PAF).

Official Title
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Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Multi-Electrode RF Balloon Catheter


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation. At least two symptomatic AF episodes within last six months from enrollment. At least one ectrocardiographically documented AF episode within twelve (12) months prior to enrollment. Failed at least one Class I or Class III antiarrhythmic drug. Age 18 -75 years. Key Exclusion Criteria: AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. Previous surgical or catheter ablation for AF. Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF > 7 days. Any percutaneous coronary intervention within the past 2 months. Valve repair or replacement or presence of a prosthetic valve. Any carotid stenting or endarterectomy within the past 6 months. Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months. Documented left atrium (LA) thrombus within 1 day prior to the index procedure. LA antero posterior diameter > 50 mm. Left Ventricular Ejection Fraction (LVEF) < 40%. Contraindication to anticoagulation (e.g., heparin). Myocardial infarction within the past 2 months. Documented thromboembolic event (including transient ischemic attack) within the past 12 months. 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. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD). Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation. Life expectancy or other disease processes likely to limit survival to less than 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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>Ablation using Multi-electrode Radiofrequency (RF) Balloon Catheter (HELIOSTAR). | Device: Multi-Electrode RF Balloon Catheter<br>* Multi-Electrode RF Balloon Catheter will be inserted<br>* Other names: HELIOSTAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of early onset Primary Adverse Events | Primary Adverse Events (PAEs) occuring within 7 days of an ablation procedure which uses the Multi-Electrode Radiofrequency Balloon Catheter. (Including atrio-esophageal fistula and PV stenosis occurring greater than seven (7) days post ablation procedure.) | 7 days | 
| Freedom of arrhythmia recurrence | The primary effectiveness endpoint for this study will be freedom from documented asymptomatic and symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter. | 3 - 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