|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P150005 S049/ PAS001 |
| Date Original Protocol Accepted |
05/29/2020
|
| Date Current Protocol Accepted |
03/25/2024
|
| Study Name |
DirectSense RF Sub-study
|
| Device Name |
IntellaNav MiFi Open-Irrigated Ablation Catheter
|
| Clinical Trial Number(s) |
NCT03232645
NCT03729830
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of the DirectSense RF sub-study is to collect data to support the use and labeling for the new DIRECTSENSE™ RF feature used with IntellaNav MiFi Open Irrigated Ablation Catheters to treat Paroxysmal Atrial Fibrillation.
|
| Study Population |
The sub-study will enroll patients from the INTERRUPT AF PAS who are treated using the DirectSense RF feature during the cardiac ablation procedure.
|
| Sample Size |
156 subjects treated with DirectSense RF from INTERRUPT AF PAS will be included in the DirectSense RF sub-study.
|
| Key Study Endpoints |
Safety: The primary safety endpoint is defined as the safety event-free rate at 12 months post-procedure.
Effectiveness: The primary effectiveness endpoint is defined as the event-free rate at 12 months post-procedure
|
| Follow-up Visits and Length of Follow-up |
3 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
414
|
| Actual Number of Sites Enrolled |
25
|
| Patient Follow-up Rate |
102 withdrawals. 84.1% with complete primary safety endpoint data
at 12 months, 87.5% with complete primary effectiveness endpoint
data at 12 months.
|
| Final Safety Findings |
A total of 294 events have been reported overall, of which 54 are
new since the 48-month report. There have been no unanticipated
events. 20 complications were EP related. 5 deaths have been
reported (1 arrhythmic, 3 noncardiac and 1 unknown). No new
concerns.
|
| Final Effect Findings |
There have been 23 device deficiencies overall, of which only 5 are
new since the 48-month report. Acute procedural success is defined
as pulmonary vein isolation achieved with a Boston Scientific OI
ablation catheter as demonstrated by map-based entrance block with
exit block and other maneuvers (such as adenosine testing) at the
discretion of the physician. The acute procedural success rate was
97.13%. Eleven (11) subjects had acute procedural failures. Of these
acute failures, 3 used a non-Boston Scientific catheter at index
procedure to ablation the pulmonary veins, 7 did not have
documented evidence of entrance/exit block for all clinically
relevant PVs, and one did not ablate all clinically relevant PVs. The
observed event-free rate at 12 months follow-up was 96.4% with a
one-sided 95% confidence limit of 94.0%. The lower confidence
limit is greater than the performance goal of 86%, resulting in a
rejection of the null hypothesis and the primary safety endpoint is
met. Ten (10) of the 276 subjects in the primary safety endpoint
analysis experienced a safety event prior to the 12-month follow-up.
A total of 294 events have been reported overall, of which 54 are
new since the 48-month report. There have been no unanticipated
events. 20 complications were EP related. 5 deaths have been
reported (1 arrhythmic, 3 noncardiac and 1 unknown).
|
| Study Strengths & Weaknesses |
The sponsor requested early termination of the INTERRUPT (Zero)
AF PAS, the INTERRUPT AF PAS, and the DirectSense RF Substudy
due to challenges with enrollment, site fatigue, patient burden,
and other factors. Based on the completion of study enrollment and
additional data from literature, registries, and adverse event
reporting, the FDA review team agreed to the early termination.
|
| Recommendations for Labeling Changes |
N/A
|
