TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study

Study Overview
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Brief Summary
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A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.

Detailed Description
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The TactiCath Quartz PAS is a prospective, non-randomized, multicenter, interventional study to evaluate the continued safety and effectiveness of the TactiCath Quartz Set for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using contact force assisted irrigated RF ablation. Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will be screened for enrollment. Patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated following the standard of care at each study site. After the index procedure, subjects will be followed for a total of 60 months. During the 3-month blanking period following ablation, subjects may undergo up to 2 repeat ablation procedures (up to 10 days prior to end of the blanking period) using the same device used during ablation. Subjects will be evaluated at pre-discharge, at 7 days, at 3, 6 and 12 months post-index procedure and then yearly thereafter. Subjects will complete Holter monitoring at 3- and 6- months post index ablation procedure and at yearly intervals beginning at 12 months post-index ablation procedure.

Official Title
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TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: TactiCath Quartz treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is planned to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I IV antiarrhythmic drug Minimum of one episode of PAF greater than 30 seconds in duration within 12 months prior to enrollment documented by 12 lead electrocardiogram (ECG), Holter monitor, trans-telephonic event monitor, telemetry strip, or implanted device Minimum of 3 episodes of PAF within the preceding 12 months documented by patient history Patient is 18 years of age or older Patient is willing and capable of complying unassisted with the study protocol requirements including all specified follow up visits Patient provides written informed consent prior to enrollment in the study Exclusion Criteria: Persistent or long-standing persistent atrial fibrillation (AF) Patient has had 4 or more cardioversions in the past 12 months. Active systemic infection Presence of implantable cardiac defibrillator (ICD) Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months Left atrial diameter > 5.0 cm Left ventricular ejection fraction < 35% New York Heart Association (NYHA) class III or IV Previous left atrial ablation procedure, either surgical or catheter ablation Patient has had a left atrial surgical procedure or incision with resulting scar Previous tricuspid or mitral valve replacement or repair Heart disease in which corrective surgery is anticipated within 6 months Bleeding diathesis or suspected pro coagulant state Contraindication to long term antithromboembolic therapy Presence of any condition that precludes appropriate vascular access Renal failure requiring dialysis Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication Contraindication to computed tomography and magnetic resonance angiography Severe 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 severe chronic symptoms Positive pregnancy test results for female patients of childbearing potential Patient has other anatomic or co morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirements, or impact the scientific soundness of the study results Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this study Patient is unlikely to survive the protocol follow up period of 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: TactiCath Quartz<br>TactiCath Quartz treatment | Device: TactiCath Quartz treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) | Rate of subjects free from symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period compared to a stated performance goal. Procedural failure defined by any of the following events: (1) Documented recurrence of AF/AFL/AT during the 9-month observational period lasting longer than 30 seconds; (2) Repeat ablation following the blanking period; or (3) Use of s new anti-arrhythmic drug for the documented symptomatic atrial arrhythmia following the blanking period. | 12 Months post ablation | 
| Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event | The rate of device or procedure serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, compared to a stated performance goal. | 7 days |