Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)

Study Overview
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Brief Summary
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Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and 50 subjects will be treated using the ST catheter with EPU. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Bayesian adaptive design will be used to assess early success at up to two interims: one after all subjects have completed the 3- month follow-up assessment, and a second to occur after all subjects have completed the 6 months follow-up visit.

Detailed Description
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Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and 50 subjects will be treated using the ST catheter with EPU. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Bayesian adaptive design will be used to assess early success at up to two interims: one after all subjects have completed the 3- month follow-up assessment, and a second to occur after all subjects have completed the 6 months follow-up visit. The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of Tag Index-guided ablation using the VISITAG SURPOINT™ Module with External Processing Unit when used with the THERMOCOOL SMARTTOUCH® SF (STSF) and THERMOCOOL SMARTTOUCH® (ST) catheters for pulmonary vein isolation (PVI) in the treatment of subjects with drug refractory symptomatic paroxysmal atrial fibrillation. Specifically: To demonstrate the safety based on the proportion of subjects with early-onset (within 7 days of ablation procedure) primary adverse events To demonstrate the 12-month effectiveness based on the proportion of subject with freedom from documented atrial arrhythmia (atrial fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL) episodes during the effectiveness evaluation period (Day 91-365)

Official Title
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Evaluation of the VISITAG SURPOINT™ Module With External Processing Unit (EPU) When Used With the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI) (SURPOINT COA)

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Catheter ablation with EPU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: Symptomatic paroxysmal AF who had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor or telemetry strip Failed at least one antiarrhythmic drug (AAD) (Class I or III antiarrhythmic drugs) 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: Subjects who meet any of the following exclusion criteria are not eligible for enrollment. Previous surgical or catheter ablation for atrial fibrillation Previous cardiac surgery (including CABG) 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 LA thrombus on imaging LA size > 50 mm (parasternal long axis view) LVEF < 40% Contraindication to anticoagulation (heparin or warfarin) History of blood clotting or bleeding abnormalities PCI/MI within the past 2 months (60 days) Documented thromboembolic event (including TIA) within the past 12 months (365 days) Rheumatic Heart Disease Uncontrolled heart failure or 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. Presence of implanted ICD/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 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) Concurrent enrollment in an investigational study evaluating another device, biologic, or drug. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes vascular access, or manipulation of the catheter. 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: VISITAG SURPOINT Module with EPU<br>Subjects undergoing electrophysiology mapping and RF ablation with THERMOCOOL SMARTTOUCH ® SF (STSF) and THERMOCOOL SMARTTOUCH ® (ST) catheters with VISITAG SURPOINT Module with External Processing Unit for pulmonary vein isolation | Device: Catheter ablation with EPU<br>* Subjects undergoing electrophysiology mapping and RF ablation with THERMOCOOL SMARTTOUCH ® SF (STSF) and THERMOCOOL SMARTTOUCH ® (ST) catheters with VISITAG SURPOINT Module with External Processing Unit for pulmonary vein isolation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Primary Adverse Events (PAEs) | A PAE is a serious adverse event (SAEs), which occurred within the first week (7 days) following an atrial fibrillation (AF) ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurred greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | Up to 12 months | 
| Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic) | Number of participants free from symptomatic and asymptomatic atrial tachyarrhythmias (which includes atrial fibrillation [AF], atrial flutter [AFL], and atrial tachycardia [AT]) were reported. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Cumulative PAEs | A PAE is a serious adverse event, which occurs within the first week (7 days) following an AF ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | Up to 12 months | 
| Number of Participants With Unanticipated Adverse Device Effects (UADEs) | Number of participants with UADEs was reported. | Up to 12 months | 
| Number of Participants With Serious Non-Primary AEs | Serious non-primary adverse events were defined as serious AEs (SAEs) that are not primary adverse events. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | Up to 12 months | 
| Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset | Number of participants with bleeding complication by ISTH class and timing of onset were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (>=) 2 grams per deciliter (g/dL), transfusion of >= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events. | Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 12 Months) | 
| Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure | Percentage of participants with ipsilateral PVI (entrance block) at the end of the procedure were reported. | End of the Procedure (up to 12 months) | 
| Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection | Percentage of participants with ipsilateral PVI after first encirclement without Acute reconnection was reported. | Up to 12 months | 
| Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins | Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins was reported. | Up to 12 months | 
| Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement | Percentage of targeted veins with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV). | Up to 12 months | 
| Number of Participants Who Underwent Repeat Ablation Procedures | Number of participants who underwent repeat ablation procedures were reported. | Up to 12 months | 
| Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure | Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure was reported. | Up to 12 months | 
| Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure | Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure was reported. | Up to 12 months | 
| Percentage of Participants With 12-Month Single Procedure Success | Percentage of participants with 12-month single procedure success was reported. It is defined as freedom from 1) any repeat procedure for Atrial fibrillation (AF)/Atrial tachycardia (AT)/Atrial flutter (AFL) post index procedure; 2) any class I/III AAD taking during the evaluation period; 3) documented AF/AT/AFL recurrence in evaluation period. | Up to 12 months |