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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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Zero-AF PAS


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General
Study Status Progress Adequate
Application Number P150005 S014/ PAS001
Date Current Protocol Accepted  
Study Name Zero-AF 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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description The INTERRUPT AF study is a global, prospective, non-randomized, multicenter study, to assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with the Blazer and IntellaNav Open-Irrigated Ablation Catheters to treat Paroxysmal Atrial Fibrillation for de novo cases.
Study Population Description The study will enroll patients with symptomatic drug-refractory paroxysmal atrial fibrillation undergoing AF ablation.
Sample Size The sample size of 415 subjects’ enrollment at 25-50 centers worldwide will ensure the minimum of 329 treatment subjects in the study. The calculation of sample size is driven by hypothesis. The sample size required to assess the Primary Safety Endpoint hypothesis was 329.

The assumptions for the sample size calculation were an expected primary safety endpoint event-free rate at one year of 90%, a performance goal of 85%, an alpha of 0.05, 80% power, and an expected attrition (per year) of 7.5%. The performance goal of 85% is based on the Primary Safety Endpoint results from the ZERO-AF clinical study data (G120082).
Data Collection The primary safety endpoint will be evaluated by the primary safety event-free rate at 12 months post-procedure. Primary safety events will consist of a composite of acute primary safety events (events occurring within seven days post-procedure or hospital discharge, whichever is later), and chronic primary safety events (events occurring through 3 months or 12 months post-procedure). Acute primary safety events will be defined as the following:

Death

Myocardial infarction (MI)

Vagal Nerve Injury/Gastroparesis

Transient ischemic attack (TIA)

Stroke/Cerebrovascular accident (CVA)

Thromboembolism

Pericarditis

Cardiac tamponade/perforation

Pneumothorax

Vascular access complications

Pulmonary edema/heart failure

AV block

Chronic primary safety events will be defined as the following:

Atrial esophageal fistula (occurring through 3 months)

Pericardial effusion (ocurring through 3 months)

Pulmonary vein stenosis (symptomatic and requiring intervention) (occurring through 12 months)

Primary effectiveness events will be defined as the following:

Acute procedural failure

More than one repeat procedure during the blanking period (90 days post index procedure)

Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (greater than or equal to 30 seconds in duration from an event monitor or Holter Monitor, or from a 10 second 12-lead EKG) between 91 days and 365 days post index procedure

Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between 91 days and 365 days post index

procedure:

Repeat procedure

Cardioversion

Prescribed any anti-arrhythmic drugs* (AAD*)

*AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for control of AF/AT/AFL recurrence

The objective of the secondary effectiveness endpoint is that the secondary effectiveness event-free rate at 12 months post-procedure in each cohort is greater than the specified performance goal 50% for De Novo Cohort.

Secondary effectiveness events will be defined as the following:

Acute procedural failure

More than one repeat procedure during the blanking period (90 days post index procedure)

Documented symptomatic atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (greater than or equal to 30 seconds in duration from an event monitor or Holter, or from a 10 second 12-lead EKG) between 91 days and 365 days post index procedure

Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between 91 days and 365 days post index

procedure:

Repeat procedure

Cardioversion

Prescribed a higher dose of any AAD* documented at baseline

Prescribed a new AAD* not documented at baseline

*AADs for endpoint will consist of all Class I/III and Class II/IV medications taken for control of AF/AT/AFL recurrence

Tertiary Endpoint:

Chronic Effectiveness: Evaluation of chronic recurrence at 24 months and 36 months.

Center Experience: Outcomes in centers performing five or more procedures using the Blazer OI catheter during the ZERO AF IDE study will

be compared to all other centers in the study using descriptive statistics.

Safety: Reportable Adverse Events rates at 12, 24 and 36 months.

Reportable events include:

All Serious Adverse Events

All Study Procedure-Related Adverse Events

All Study Device-Related Adverse Events

All Study Device Deficiencies

Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects

previously not defined in the Directions For Use.

Effectiveness: Acute Procedural Succe
Follow-up Visits and Length of Follow-up The patients in De Novo cohort will be followed for 3 years.


Zero-AF PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/21/2018 07/17/2018 Overdue/Received
one year report 12/21/2018 01/31/2019 Overdue/Received
18 month report 06/21/2019 04/26/2019 On Time
two year report 11/01/2019 10/31/2019 On Time
three year report 11/01/2020    
four year report 11/01/2021    
five year report 11/01/2022    
final report 11/01/2023    


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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