Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.

Official Title
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Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must provide written informed consent prior to any clinical investigation related procedure. Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7-days and less than 1-year that is documented by (1) a physician's note and (2) a 24-hour Holter within 90-days prior to the procedure, showing continuous AF Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF Age 18 years or older Able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: Continuous AF > 12 months (longstanding persistent AF) Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial procedure CABG surgery within the 6-months (180-days) prior to the initial procedure Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve) Any carotid stenting or endarterectomy Documented or known left atrial thrombus on imaging Left atrial diameter > 50 mm (parasternal long axis view or by CT) Left ventricular ejection fraction < 40% Unable to take anticoagulation medication due to contraindication or intolerance History of blood clotting or bleeding abnormalities Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI) within the 3-months (90-days) prior to the initial procedure Documented thromboembolic event (including TIA) within the 12-months (365 days) prior to the initial procedure Rheumatic heart disease Uncontrolled heart failure or NYHA functional 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 12-months (365 days) following the initial ablation procedure Unstable angina at the time of the initial procedure Acute illness or active systemic infection or sepsis AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, major surgical procedure in the preceding 3-months, or other reversible or non-cardiac cause Diagnosed atrial myxoma Presence of implanted implantable cardioverter defibrillator (ICD) or 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 Significant congenital anomaly or other anatomic or comorbid medical problem that in the opinion of the investigator would preclude enrollment in this study or compliance with the follow-up requirements or impact the scientific soundness of the clinical trial results Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period Enrollment in an investigational study evaluating another device, biologic, or drug that may interfere with this clinical investigation at the time of the initial procedure or within 30 days prior to the initial procedure Presence of any condition that precludes appropriate vascular access or manipulation of catheter Life expectancy less than 12-months Body mass index > 40 kg/m2 Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication Renal failure requiring dialysis Vulnerable subject History of atriotomy or ventriotomy Implanted endocardial left atrial appendage occlusion device

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: Ablation<br>Enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE). | Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™<br>* Ablation procedure for Persistent AF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Subjects With a Device and/or Procedure-related SAE. | Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device. | Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure | 
| Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence. | The following events were considered a failure for AF/AFL/AT recurrence: If AF/AFL/AT recurrence (>30 second episode) occurred at any time after the therapy consolidation period (>180 days after the initial procedure), or If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a >30 second AF/AFL/AT episode, or If the subject required a second repeat procedure at any time after the initial procedure, or If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Procedural Success | Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins | Immediate post procedure | 
| 15-month Success Off of Antiarrhythmic Drugs | Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods. | 15 months | 
| 15 Month Single Procedure Success | Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis. | 15 months |