Trial Outcomes & Findings for Safety and Performance Study of the INGEVITY Lead (NCT NCT01688843)
NCT ID: NCT01688843
Last Updated: 2020-03-10
Results Overview
Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1060 participants
Primary outcome timeframe
Lead implant through 3 month follow up
Results posted on
2020-03-10
Participant Flow
Unit of analysis: Leads
Participant milestones
| Measure |
INGEVITY Study Participants
Each participant was allowed to have up to 2 INGEVITY leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle). Final lead implanted or attempted during initial procedure per chamber was used for analysis.
|
|---|---|
|
Overall Study
STARTED
|
1060 1599
|
|
Overall Study
COMPLETED
|
1060 1599
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Performance Study of the INGEVITY Lead
Baseline characteristics by cohort
| Measure |
INGEVITY Lead
n=1060 Participants
INGEVITY lead implant
|
|---|---|
|
Age, Continuous
|
74.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
478 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
582 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
11 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
603 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
88 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
8 participants
n=5 Participants
|
|
Region of Enrollment
France
|
57 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Lead implant through 3 month follow upPopulation: Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.
Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%
Outcome measures
| Measure |
INGEVITY Lead
n=1599 Implant/Attempted Leads
Implanted/Attempted Leads
|
|---|---|
|
Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)
|
98.4 percentage of leads complication-free
Interval 97.7 to
One-sided confidence interval
|
PRIMARY outcome
Timeframe: 3 months through 12 months post implantPopulation: Leads still in service and implanted in actively followed participants at 92 days were included in analysis.
Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%.
Outcome measures
| Measure |
INGEVITY Lead
n=1545 Implant/Attempted Leads
Implanted/Attempted Leads
|
|---|---|
|
Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)
|
99.7 percentage of leads complication-free
Interval 99.4 to
One-sided confidence interval
|
PRIMARY outcome
Timeframe: Implant through 12 months (including available data beyond 12 months)Population: Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.
Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (\>1), equal to one (=1) and less than one (\<1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1.
Outcome measures
| Measure |
INGEVITY Lead
n=1599 Leads Implanted/Attempted
Implanted/Attempted Leads
|
|---|---|
|
Safety 3 - Hazard Rate of Lead-Related Complications
|
0.23 hazard rate of lead-related complication
Interval to 0.3
One-sided confidence interval
|
PRIMARY outcome
Timeframe: Lead implant through 3 month follow upThe bipolar pacing threshold at 0.5 ms at three months post-implant \< 1.5 V
Outcome measures
| Measure |
INGEVITY Lead
n=1482 Implant/Attempted Leads
Implanted/Attempted Leads
|
|---|---|
|
Effectiveness 1
|
0.67 volts
Interval 0.65 to 0.69
|
PRIMARY outcome
Timeframe: Lead implant through 3 month follow upP-wave sensed amplitude at three months post-implant \> 1.5 mV
Outcome measures
| Measure |
INGEVITY Lead
n=521 Implant/Attempted Leads
Implanted/Attempted Leads
|
|---|---|
|
Effectiveness 2(Right Atrium)
|
4.8 mV
Interval 4.6 to
One-sided confidence interval
|
PRIMARY outcome
Timeframe: Lead implant through 3 month follow upR-wave sensed amplitude at three months post-implant \> 5 mV
Outcome measures
| Measure |
INGEVITY Lead
n=914 Implant/Attempted Leads
Implanted/Attempted Leads
|
|---|---|
|
Effectiveness 2(Right Ventricle)
|
16.5 mV
Interval 16.2 to
One-sided confidence interval
|
PRIMARY outcome
Timeframe: Lead implant through 3 month follow upClinically acceptable pacing impedance between 300 Ω and 1300 Ω
Outcome measures
| Measure |
INGEVITY Lead
n=1526 Implant/Attempted Leads
Implanted/Attempted Leads
|
|---|---|
|
Effectiveness 3
|
773 Ω
Interval 766.0 to 779.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 3 to 60 months post-implantPopulation: Leads eligible for endpoint analyses
Lead-related complication-free rate
Outcome measures
| Measure |
INGEVITY Lead
n=1038 Participants
Implanted/Attempted Leads
|
|---|---|
|
Ancillary Safety
|
99.1 percentage of leads complication-free
Interval 98.6 to 100.0
|
Adverse Events
INGEVITY Study Participants
Serious events: 532 serious events
Other events: 621 other events
Deaths: 93 deaths
Serious adverse events
| Measure |
INGEVITY Study Participants
n=1041 participants at risk
|
|---|---|
|
Product Issues
Pulse Generator
|
0.86%
9/1041 • Number of events 10 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Product Issues
Right Atrial (RA) Lead - INGEVITY Related
|
1.8%
10/564 • Number of events 10 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Product Issues
RA Lead - Other (Non-INGEVITY Lead)
|
1.4%
12/858 • Number of events 12 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Product Issues
Right Ventricular (RV) Lead - INGEVITY-related
|
1.4%
15/1041 • Number of events 20 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Product Issues
RV Lead - Other (Non-INGEVITY Lead)
|
0.10%
1/1041 • Number of events 1 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Product Issues
Left-Ventricular (LV) Lead
|
0.19%
2/1041 • Number of events 2 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Surgical and medical procedures
Procedure
|
2.5%
26/1041 • Number of events 26 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Cardiac disorders
Cardiovascular - Heart Failure
|
9.7%
101/1041 • Number of events 163 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Cardiac disorders
Cardiovascular - Non-Heart Failure
|
23.2%
241/1041 • Number of events 326 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
General disorders
Other
|
4.7%
49/1041 • Number of events 54 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Investigations
Unclassified
|
0.77%
8/1041 • Number of events 8 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
General disorders
Non-cardiovascular
|
34.3%
357/1041 • Number of events 705 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
Other adverse events
| Measure |
INGEVITY Study Participants
n=1041 participants at risk
|
|---|---|
|
Product Issues
Pulse Generator
|
3.1%
32/1041 • Number of events 37 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Product Issues
RA Lead - INGEVITY-related
|
2.8%
16/564 • Number of events 17 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Product Issues
RA Lead - Other
|
0.47%
4/858 • Number of events 4 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Product Issues
RV Lead - INGEVITY-related
|
1.1%
11/1041 • Number of events 11 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Product Issues
LV Lead
|
12.8%
6/47 • Number of events 7 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Surgical and medical procedures
Procedure
|
5.6%
58/1041 • Number of events 66 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Cardiac disorders
Cardiovascular - HF
|
5.9%
61/1041 • Number of events 74 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
Cardiac disorders
Cardiovascular - Non-HF
|
39.6%
412/1041 • Number of events 720 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
General disorders
Other
|
8.5%
89/1041 • Number of events 103 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
|
General disorders
Unclassified
|
0.86%
9/1041 • Number of events 10 • Entire follow-up (median participant follow-up = 30.9 months)
All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place