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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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VISITAG SURPOINT PAS


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General
Study Status Progress Adequate
Application Number P030031 S086/ PAS001
Study Name VISITAG SURPOINT PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Study Population Description 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.
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.

Data Collection 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: o Death o Atrio-esophageal fistula o Cardiac Tamponade*+-Perforation+ o Myocardial infarction (MI) o Stroke - Cerebrovascular accident (CVA) †, †† o Thromboembolism o Transient Ischemic Attack o Diaphragmatic paralysis o Pneumothorax o Heart block o PV stenosis* o Pulmonary edema (Respiratory Insufficiency) o Vagal Nerve Injury o Pericarditis o 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.
Follow-up Visits and Length of Follow-up 1 year
Interim or Final Data Summary
Interim Safety Information SAEs

Dyspnea [1] (not related to study device or procedure)

Dysphagia [1] (not related to study device or procedure)

Bradycardia [1] (not related to study device, probable relation to procedure)

Hypotension [1] (not related to study device, probable relation to procedure)

NSAEs

Pneumonia [1] (not related to study device or procedure)

Dyspnea w/ exertion [1] (not related to study device or procedure)

Abdominal bloating [1] (not related to study device or procedure)

Fatigue [1] (not related to study device, possible relation to procedure)

Bilateral lower extremity edema [1] (not related to study device, unlikely relation to procedure)



Device Malfunctions

Loss of signal, resolved by changing interface cables.



Follow-up:

Mean 44.6 days





Actual Number of Patients Enrolled 11
Actual Number of Sites Enrolled 16
Patient Follow-up Rate 100%


VISITAG SURPOINT PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/30/2018 11/30/2018 On Time
one year report 06/01/2019 05/31/2019 On Time
18 month report 11/30/2019    
two year report 05/31/2020    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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