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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P110016 S080/ PAS002 |
| Date Original Protocol Accepted |
02/24/2023
|
| Date Current Protocol Accepted |
|
| Study Name |
LESS VT NICM Post-Approval Study
|
| Device Name |
FlexAbility™ Ablation Catheter, Sensor Enabled™
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The goal of this post approval study is to confirm the safety and effectiveness of the study catheter for the treatment of
MMVT in the post-market space.
|
| Study Population |
This clinical investigation will enroll subjects of all sexes who have recurrent, drug-refractory, sustained MMVT from non-ischemic origin. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not
considered standard of care.
|
| Sample Size |
Approximately one hundred fifty (150) subjects will be enrolled in this clinical investigation at up to 25 sites in the United States for analysis of the primary endpoints. At least 50% of subjects will be greater than or equal to 65 years of age.
|
| Key Study Endpoints |
The primary safety endpoint will be the rate of study device and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure. This endpoint will be descriptively evaluated at 12 months.
Only study device (FlexAbility SE)-related adverse events related to use during Study Ablation Procedures will be collected.
The primary effectiveness endpoint is a composite of 12-month freedom from VT recurrence, death, and cardiac transplantation. This endpoint will be descriptively evaluated at 12 months. VT recurrence is defined as:
Continuous VT for >30 seconds o If the subject has continuous VT throughout a 12-lead ECG recording, this will be considered sufficient documentation of recurrence unless there is evidence that the recorded arrhythmia is short-lived and less than 30 seconds.
VT requiring intervention for termination regardless of its duration
Repeat Ablation Procedure
Use of a non-study device for ablation to the ventricles or cardiac ablation by any method other than RF energy during a Study Ablation Procedure will be considered an effectiveness failure.
There are several descriptive endpoints. These endpoints will be summarized descriptively and no hypothesis tests will be performed.
The primary safety endpoint and primary effectiveness endpoint will be summarized separately for subjects <65 years of age and subjects greater than or equal to 65 years of age
12-month all-cause mortality
12-month freedom from VT
12-month freedom from cardiac transplantation
Study device- or Study Ablation Procedure- related SAEs through 7 days
Rate of Repeat Ablation Procedures
|
| Follow-up Visits and Length of Follow-up |
Subjects will be followed for up to 12-months post-procedure
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
7
|
| Actual Number of Sites Enrolled |
5
|
| Patient Follow-up Rate |
Insufficient enrollment and duration of follow-up to determine follow-up rate.
|
| Final Safety Findings |
Insufficient enrollment and duration of follow-up to draw safety conclusions.
|
| Final Effect Findings |
Insufficient enrollment and duration of follow-up to draw effectiveness conclusions.
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