|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P010012 S160/ PAS001 |
| Date Original Protocol Accepted |
05/16/2008
|
| Date Current Protocol Accepted |
01/20/2017
|
| Study Name |
ACUITY Long-Term Registry
|
| Device Name |
ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
prospective, non-randomized, multi-center registry
|
| Study Population |
The study population will consist of patients who: were successfully implanted with the ACUITY Spiral Lead, meet the study criteria.
|
| Sample Size |
1,700 patients, 150 sites
|
| Key Study Endpoints |
Chronic LV lead-related complication-free rate over a five year follow- up period
|
| Follow-up Visits and Length of Follow-up |
Patients will be followed until they have completed five years of
follow-up from implant or until death, withdrawal, or closure of the registry.
Patients will have an in-clinic follow-up visit one month (15 to 29
days) post implant and then subsequently be followed according to the center¿s standard follow-up schedule, with complete in-clinic system interrogation recommended to be at least once every six months.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1308 subjects (out of the required 1700 subjects)
|
| Actual Number of Sites Enrolled |
94 sites
|
| Patient Follow-up Rate |
57.3%
|
| Final Safety Findings |
he one-sided 95% confidence-interval lower bounds for the mean values of the modified complication-free rate (CFR) for the following five different time points are well above the acceptance boundary of 92.5%, as given in Table below.
Interval (Years from implant)
Statistic 1 2 3 4 5
Mean % Free from Adverse Events 96.8 96.3 96.1 95.7 95.3
Lower One-Sided 95% Confidence Limit 95.9 95.3 95 94.5 94
None of the deaths were reported as LV lead-related. The final death rate per year is 7.23%.
|
| Final Effect Findings |
Percentages of patients with out-of-bound measurements are as follows: a voltage threshold (9%), pulse width (2%), pacing impedance (0%, 1 patient with pacing impedance >= 2000 ohms), and sensing amplitude out of performance standards bounds (11%) cumulatively. The 60-month occurrence rates of out-of-bound measurements are the voltage threshold (1%, >3.5V), pulse width (0%, energy output
>0.5), pacing impedance (0%, >= 2000 ohms), and sensing amplitude (1%, <= 3mV).
|
| Study Strengths & Weaknesses |
The study strengths are 1) the high modified CFR of 95.3% and its lower bound of 94% and 2) the low occurrence rates of out-of-range measurements as listed above for the final effectiveness findings. The study weakness is that only a total of 436 subjects were followed, which is smaller than the minimum 500-subject requirement often seen in other PAS’s for leads.
|
| Recommendations for Labeling Changes |
Inclusion of 1) the 5-year modified CFR and corresponding 95% one-sided confidence interval; and 2) a summary of adverse events that were and were not counted towards the 5-year modified CFR along with a clarification on intervention methods (non-invasive vs. invasive).
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