Trial Outcomes & Findings for Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study (NCT NCT01076361)
NCT ID: NCT01076361
Last Updated: 2014-10-27
Results Overview
The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.
Recruitment status
COMPLETED
Target enrollment
370 participants
Primary outcome timeframe
The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.
Results posted on
2014-10-27
Participant Flow
All enrolled patients with at least 1 Model 4968 lead implanted
Participant milestones
| Measure |
Model 4968 Leads
A total of 631 leads were implanted in 370 patients. 22 leads in 21 patients were excluded from analysis.
|
|---|---|
|
Overall Study
STARTED
|
370
|
|
Overall Study
COMPLETED
|
349
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Model 4968 Leads
A total of 631 leads were implanted in 370 patients. 22 leads in 21 patients were excluded from analysis.
|
|---|---|
|
Overall Study
22 leads were excluded from analysis
|
21
|
Baseline Characteristics
Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study
Baseline characteristics by cohort
| Measure |
All Enrolled Patients
n=370 Participants
All patients who were enrolled and implanted with a Model 4968 Lead
|
|---|---|
|
Age, Customized
Unknown
|
21 participants
n=5 Participants
|
|
Age, Customized
0 - 12 Years
|
155 participants
n=5 Participants
|
|
Age, Customized
13 - 19 Years
|
49 participants
n=5 Participants
|
|
Age, Customized
20 + Years
|
145 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
232 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity not collected
|
345 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reportable per Local Laws/Regulations
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.Population: 22 Model 4968s (in 21 participants) was not available for analysis
The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.
Outcome measures
| Measure |
Model 4968 Lead Survival Probability
n=349 Participants
Model 4968 is steroid-eluting bipolar epicardial pacing lead. Participants implanted with Model 4968 lead their data will be obtained for long-term safety and lead events, includes the survival probability for the Model 4968.
|
|---|---|
|
Survival Probability of the Model 4968 Lead Based on Lead-related Complications
|
92.3 percentage of Model 4968 Leads
Interval 88.3 to 95.04
|
Adverse Events
Model 4968 Participants
Serious events: 30 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Model 4968 Participants
n=349 participants at risk
All Model 4968 participants in the analysis cohort
|
|---|---|
|
Cardiac disorders
Over-sensing
|
1.7%
6/349 • Number of events 6 • Post Implant
All reported lead related events were adjudicated by a technical review committee and reconciled with Medtronic's Event Analysis Reporting System.
|
|
Cardiac disorders
Insulation breach
|
0.57%
2/349 • Number of events 2 • Post Implant
All reported lead related events were adjudicated by a technical review committee and reconciled with Medtronic's Event Analysis Reporting System.
|
|
Cardiac disorders
High impedance
|
0.86%
3/349 • Number of events 3 • Post Implant
All reported lead related events were adjudicated by a technical review committee and reconciled with Medtronic's Event Analysis Reporting System.
|
|
Cardiac disorders
Lead conductor fracture
|
1.7%
6/349 • Number of events 6 • Post Implant
All reported lead related events were adjudicated by a technical review committee and reconciled with Medtronic's Event Analysis Reporting System.
|
|
Cardiac disorders
Failure to capture/loss of capture
|
3.7%
13/349 • Number of events 13 • Post Implant
All reported lead related events were adjudicated by a technical review committee and reconciled with Medtronic's Event Analysis Reporting System.
|
|
Cardiac disorders
Threshold rise, Sudden
|
0.29%
1/349 • Number of events 1 • Post Implant
All reported lead related events were adjudicated by a technical review committee and reconciled with Medtronic's Event Analysis Reporting System.
|
|
Cardiac disorders
Failure to sense
|
1.1%
4/349 • Number of events 4 • Post Implant
All reported lead related events were adjudicated by a technical review committee and reconciled with Medtronic's Event Analysis Reporting System.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60