Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)

Study Overview
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Brief Summary
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This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

Detailed Description
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The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug refractory symptomatic persistent atrial fibrillation (PsAF) following standard electrophysiology mapping and radio frequency (RF) ablation procedures.

Official Title
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Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: THERMOCOOL SMARTTOUCH® SF catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates for this study must meet ALL of the following criteria: Documented symptomatic persistent AF, which is defined as continuous AF sustains beyond 7 days and less than 1 year and is documented by the following:. Physician's note indicating continuous AF ≥ 7 days but no more than 1 year; AND Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart OR 24-hour Holter within 90 days of the ablation procedure showing continuous AF Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD. Age 18 years or older. Signed Patient Informed Consent Form (ICF). Able and willing to comply with all pre-, post-, and follow-up testing and requirements. Exclusion Criteria: Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply: Continuous AF > 12 months (1-Year) (Longstanding Persistent AF) Previous surgical or catheter ablation for atrial fibrillation Any cardiac surgery within the past 2 months (60 days) (includes percutaneous coronary intervention (PCI)) Coronary Artery Bypass Graft (CABG) surgery within the past 6 months (180 days) Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) Any carotid stenting or endarterectomy Documented left atrial (LA) thrombus on imaging LA size > 50 mm (parasternal long axis view) 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 (60 days) Documented thromboembolic event (including Transient Ischemic Attack (TIA) within the past 12 months (365 days) Rheumatic Heart Disease Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2) Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days) Unstable angina Acute illness or active systemic infection or sepsis AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. Diagnosed atrial myxoma. Presence of implanted implantable cardioverter defibrillator (ICD) /cardiac resynchronization therapy defibrillator (CRT-D). 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. Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including over-the-counter (OTC) medication) 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 any other condition that precludes appropriate vascular access. Life expectancy less than 12 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 (PVI) by RF ablation treatment with the THERMOCOOL SMARTTOUCH® SF catheter in persistent AF population. | Device: THERMOCOOL SMARTTOUCH® SF catheter<br>* Radiofrequency Ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days | The primary safety endpoint is the incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE), which are listed below: Death Atrio-esophageal fistula* Cardiac Tamponade**+/Perforation+ Myocardial infarction (MI) Stroke / Cerebrovascular accident (CVA) †, †† Thromboembolism Transient Ischemic Attack Diaphragmatic paralysis Pneumothorax Heart block PV stenosis* Pulmonary edema (Respiratory Insufficiency) Pericarditis Major Vascular access complication / bleeding | 7 days (except as noted in analysis population description) | 
| Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up | The primary effectiveness endpoint for this study will be freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 15-month follow-up (post 3-Month Medication Adjustment Period followed by a 3-Month Therapy Consolidation period (Day 181-450)) and freedom from the following failure modes: Acute Procedural Failure Non-Study Catheter Failure Repeat Ablation Failure AAD Failure Surgical Failure | 15-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Procedural Success | Acute procedural success is defined as confirmation of entrance block in all pulmonary veins. | Immediate post-procedure | 
| 15-Month Single Procedure Success | The 15-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes > 30 secs) during the Evaluation Period after a single ablation procedure. Any repeat ablation procedure during the Evaluation Period will be deemed effectiveness failure for this analysis. | 15-Month | 
| Early Onset Serious Adverse Event (SAE) | Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event | 7 days | 
| Peri-Procedural Serious Adverse Event (SAE) | Peri-Procedural (>7 to 30 days) Serious Adverse Event | >7 to 30 days | 
| Late Onset Serious Adverse Event (SAE) | Occurrence of Late Onset (>30 days) Serious Adverse Event | >30 days up to 15 months | 

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