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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030031 S086/ PAS001 |
| Date Original Protocol Accepted |
06/01/2018
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| Date Current Protocol Accepted |
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| Study Name |
VISITAG SURPOINT PAS
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| Device Name |
Visitag Surpoint External Processing Unit (EPU)
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, multi-center, single-arm study. Primary safety and effectiveness endpoints will be compared to pre-determined performance goals.
This is a new enrollment study.
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| Study Population |
Subjects (age 18 years or above) undergoing electrophysiology mapping and RF ablation with STSF and ST catheter for treatment of antiarrhythmic drug refractory symptomatic paroxysmal AF.
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| Sample Size |
A total of 330 subjects (280 treated with STSF catheter with EPU and 50 treated with ST catheter with EPU) enrolled from up to 45 U.S. sites.
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| Key Study Endpoints |
Primary effectiveness endpoint:
Freedom from documented (symptomatic and asymptomatic) atrial fibrillation, atrial flutter and atrial tachycardia (AF-AFL-AT) (hereinafter collectively referred to as “atrial tachyarrhythmias") recurrence (episodes = 30 secs on TTM or continuously recorded on the standard 12-leads ECG or Holter) during the eval period (Day 91-365) & freedom from the following failure modes: Acute procedural failure, including: Failure to confirm entrance block in all pulmonary veins at the end of procedure • Repeat ablation failure, including: o >1 repeat ablation procedures during the 3-Month Blanking Period (Day 0-90) after the index ablation procedure. Any repeat ablation procedure during the evaluation period.
• DC cardioversion for AF-AFL-AT following the 3-month blanking period • Surgical treatment for AF-AFL-AT after the index ablation procedure.
• AAD failure: Taking a new AAD for AF, a previously failed AAD at a greater than the highest ineffective historical dose or starting an AAD for AF during the evaluation period. Primary safety endpoint: Any PAE occurring within 7 days following an AF ablation procedure (including the initial and repeat procedures) using the STSF-ST catheter with EPU, except atrio-esophageal fistula and PV stenosis, which may also be considered as primary adverse events if occurring greater than 7 days post the ablation procedure. PAE include the following conditions: - 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) - Vagal Nerve Injury - Pericarditis - Major vascular access complication-bleeding Hemodynamic compromise or instability is defined as Systolic BP < 80 mm Hg. + Cardiac Tamponade-Perforation occurring within 30 days of the AF ablation process will be considered Primary AEs † Subjects with non-focal global encephalopathy will not be reported as a stroke without unequivocal evidence based upon neuroimaging studies. Modified Rankin score assessments should be made by certified individuals.
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| Follow-up Visits and Length of Follow-up |
1 year
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
333 signed informed consent, 310 treated (261 with Thermocool SmartTouch SF (STSF), 49 with Thermocool SmartTouch (ST))
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| Actual Number of Sites Enrolled |
35 investigational sites in United States and outside United States
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| Patient Follow-up Rate |
95.5% STSF and 92.9% ST
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| Final Safety Findings |
Overall, the data provided suggest a reasonable assurance of safety and effectiveness of the device use with the SFST and ST catheters in Tag Index-guided PV isolation for the treatment of PAF.
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| Final Effect Findings |
The results of the planned interim analysis suggest that the PAS has met the pre-specified early success criteria. Both the primary effectiveness and safety performance goals were met in the STSF subjects.
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| Study Strengths & Weaknesses |
see above
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| Recommendations for Labeling Changes |
Labeling updated with additional information on usage of VISITAG SURPOINT feature with specified catheters (P030031/S110).
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