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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P150005 S014/ PAS001 |
| Date Original Protocol Accepted |
11/01/2018
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| Date Current Protocol Accepted |
03/25/2024
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| Study Name |
INTERRUPT (Zero) AF PAS
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| Device Name |
Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter
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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 |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
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.
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| Study Population |
The study will enroll patients with symptomatic drug-refractory paroxysmal atrial fibrillation undergoing AF ablation.
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| 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).
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| Key Study Endpoints |
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 Success Rate
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| Follow-up Visits and Length of Follow-up |
The patients in De Novo cohort will be followed for 3 years.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
350
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| Actual Number of Sites Enrolled |
25
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| Patient Follow-up Rate |
45 withdrawals
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| Final Safety Findings |
215 of the 350 enrolled subjects have completed their 12 months visit and 37 have completed their 36 months visit. A total of 240 events have been reported overall, of which 75 are new since the 36-month report. There have been no unanticipated events. 18 complications were EP related, including 5 pericardial effusions. 2 deaths have been reported - these were from the 36-month report. No new concerns at this time.
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| Final Effect Findings |
There have been 18 device deficiencies overall, of which only 2 are new since the 36-month report
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