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|
| General |
| Study Status |
Progress Adequate |
Application Number /
Requirement Number |
P150026 S002/ PAS001 |
| Date Original Protocol Accepted |
05/02/2018
|
| Date Current Protocol Accepted |
07/01/2020
|
| Study Name |
CF HeartLight PAS
|
| Device Name |
Heart Light Catheter with Excalibur Balloon
|
| 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 Objectives |
The purpose of this study is to evaluate the long-term safety and effectiveness of the device in a commercial population and to clarify the safety profile of the device among females. This will be accomplished through a new enrollment prospective single-armed study.
|
| Study Population |
Study subjects will be clinically eligible for treatment of paroxysmal atrial fibrillation with the HeartLight device.
|
| Sample Size |
250 subjects will be enrolled at up to 25 sites in the US, and a minimum 135 of those subjects will be female, will accommodate the hypothesis testing with 80% power and an alpha of 0.025 for each of the hypotheses.
|
| Key Study Endpoints |
The primary effectiveness endpoint will be freedom from symptomatic Atrial Fibrillation at one-year, and will be compared to a performance goal of 55% of subjects free from symptomatic AF at one year.
The primary safety outcome for the entire cohort will be the percentage of subjects experiencing a Primary Adverse Event by one-year of follow-up, and will be compared to a performance goal of PAE rate of 14% at one year.
The same safety outcome will be assessed for females with the same performance goal.
Longer term (three year) safety and effectiveness will be assessed as secondary outcomes.
The long-term effect of operator experience will also be assessed as a secondary outcome.
If there are gender differences in safety outcomes, the factors contributing to these differences will be evaluated as secondary outcomes.
All safety, effectiveness, and operator training results will also be stratified by version of the HeartLight Endoscopic Ablation System (i.e. with or without Excalibur Catheter) as an additional descriptive analysis.
|
| Follow-up Visits and Length of Follow-up |
Study subjects will be followed for three years.
All subjects will undergo clinical follow-up pre-discharge, at 30 days, 90 days, 12 months, 24 months, and 36 months
|
| Interim or Final Data Summary |
| Interim Results |
14.0% serious adverse event rate (40.7% total adverse event rate).
95.6% overall acute success rate.
|
| Actual Number of Patients Enrolled |
91
|
| Actual Number of Sites Enrolled |
10
|
| Patient Follow-up Rate |
98% at 12 months
|
| Study Strengths & Weaknesses |
Subject enrollment increasing, number of study sites increasing.
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