Trial Outcomes & Findings for Retrospective Experience Of CIED Implantation (NCT NCT04351269)
NCT ID: NCT04351269
Last Updated: 2023-07-21
Results Overview
Major CIED infections are defined as a CIED infection resulting in one or more of the following: * CIED system removal * Any invasive procedure (e.g., pocket opened) without system removal * Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage * Death
Recruitment status
COMPLETED
Target enrollment
597 participants
Primary outcome timeframe
12 months post procedure
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
CanGaroo Envelope
Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.
CanGaroo Envelope: CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation
|
TYRX Envelope
Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.
TYRX Envelope: TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation
|
No Envelope
Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.
|
|---|---|---|---|
|
Overall Study
STARTED
|
237
|
260
|
100
|
|
Overall Study
COMPLETED
|
165
|
219
|
71
|
|
Overall Study
NOT COMPLETED
|
72
|
41
|
29
|
Reasons for withdrawal
| Measure |
CanGaroo Envelope
Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.
CanGaroo Envelope: CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation
|
TYRX Envelope
Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.
TYRX Envelope: TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation
|
No Envelope
Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.
|
|---|---|---|---|
|
Overall Study
Subjects did not meet Inclusion criteria after protocol revision B
|
70
|
32
|
29
|
|
Overall Study
CanGaroo Envelope used during a previous procedure
|
0
|
1
|
0
|
|
Overall Study
Subjects had both CanGaroo Envelope and TYRX Envelope used during procedure
|
1
|
1
|
0
|
|
Overall Study
Subjects followed long-term at different health care system
|
0
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
Baseline Characteristics
Retrospective Experience Of CIED Implantation
Baseline characteristics by cohort
| Measure |
CanGaroo Envelope
n=165 Participants
Patients who received a CanGaroo Envelope with their CIED implantation.
CanGaroo Envelope: CanGaroo Envelope with CIED implantation
|
TYRX Envelope
n=219 Participants
Patients who received a TYRX Envelope with their CIED implantation.
TYRX Envelope: TYRX Envelope with CIED implantation
|
No Envelope
n=71 Participants
Patients who had their CIED implanted with no envelope.
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
74.0 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
70.3 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
74.2 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
72.3 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
288 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
433 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
143 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
390 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
BMI, Continuous
|
28.6 kg/m²
STANDARD_DEVIATION 6.5 • n=5 Participants
|
30.6 kg/m²
STANDARD_DEVIATION 7.2 • n=7 Participants
|
31.0 kg/m²
STANDARD_DEVIATION 6.3 • n=5 Participants
|
29.9 kg/m²
STANDARD_DEVIATION 6.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 months post procedureMajor CIED infections are defined as a CIED infection resulting in one or more of the following: * CIED system removal * Any invasive procedure (e.g., pocket opened) without system removal * Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage * Death
Outcome measures
| Measure |
CanGaroo Envelope
n=165 Participants
Patients who received a CanGaroo Envelope with their CIED implantation.
CanGaroo Envelope: CanGaroo Envelope with CIED implantation
|
TYRX Envelope
n=219 Participants
Patients who received a TYRX Envelope with their CIED implantation.
TYRX Envelope: TYRX Envelope with CIED implantation
|
No Envelope
n=71 Participants
Patients who had their CIED implanted with no envelope.
|
|---|---|---|---|
|
Number of Participants With Major Infection Post Procedure
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months post procedureAny pocket related issues that prompted an office visit
Outcome measures
| Measure |
CanGaroo Envelope
n=165 Participants
Patients who received a CanGaroo Envelope with their CIED implantation.
CanGaroo Envelope: CanGaroo Envelope with CIED implantation
|
TYRX Envelope
n=219 Participants
Patients who received a TYRX Envelope with their CIED implantation.
TYRX Envelope: TYRX Envelope with CIED implantation
|
No Envelope
n=71 Participants
Patients who had their CIED implanted with no envelope.
|
|---|---|---|---|
|
Number of Participants With Pocket Related Issues Prompting an Office Visit
Superficial Surgical Site Infection (SSI)
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Pocket Related Issues Prompting an Office Visit
Hematoma
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Pocket Related Issues Prompting an Office Visit
Pocket Infection
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pocket Related Issues Prompting an Office Visit
Lead Dislodgement
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Pocket Related Issues Prompting an Office Visit
Site Drainage
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pocket Related Issues Prompting an Office Visit
Thrombosis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pocket Related Issues Prompting an Office Visit
Lead Revision
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Pocket Related Issues Prompting an Office Visit
Hemothorax
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Pocket Related Issues Prompting an Office Visit
Erythema & Fever
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
CanGaroo Envelope
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
TYRX Envelope
Serious events: 7 serious events
Other events: 0 other events
Deaths: 10 deaths
No Envelope
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CanGaroo Envelope
n=165 participants at risk
Patients who received a CanGaroo Envelope with their CIED implantation.
CanGaroo Envelope: CanGaroo Envelope with CIED implantation
|
TYRX Envelope
n=219 participants at risk
Patients who received a TYRX Envelope with their CIED implantation.
TYRX Envelope: TYRX Envelope with CIED implantation
|
No Envelope
n=71 participants at risk
Patients who had their CIED implanted with no envelope.
|
|---|---|---|---|
|
Cardiac disorders
Hematoma
|
1.2%
2/165 • Number of events 2 • 12 months post-procedure
|
0.91%
2/219 • Number of events 2 • 12 months post-procedure
|
0.00%
0/71 • 12 months post-procedure
|
|
Cardiac disorders
Pocket Infection
|
1.2%
2/165 • Number of events 2 • 12 months post-procedure
|
0.00%
0/219 • 12 months post-procedure
|
0.00%
0/71 • 12 months post-procedure
|
|
Cardiac disorders
Lead Dislodgement
|
0.61%
1/165 • Number of events 1 • 12 months post-procedure
|
0.91%
2/219 • Number of events 2 • 12 months post-procedure
|
1.4%
1/71 • Number of events 1 • 12 months post-procedure
|
|
Cardiac disorders
Superficial Surgical Site Infection
|
0.61%
1/165 • Number of events 1 • 12 months post-procedure
|
0.46%
1/219 • Number of events 1 • 12 months post-procedure
|
0.00%
0/71 • 12 months post-procedure
|
|
Cardiac disorders
Lead Revision
|
0.00%
0/165 • 12 months post-procedure
|
0.46%
1/219 • Number of events 1 • 12 months post-procedure
|
0.00%
0/71 • 12 months post-procedure
|
|
Cardiac disorders
Hemothorax
|
0.00%
0/165 • 12 months post-procedure
|
0.46%
1/219 • Number of events 1 • 12 months post-procedure
|
0.00%
0/71 • 12 months post-procedure
|
|
Cardiac disorders
Thrombosis
|
0.61%
1/165 • Number of events 1 • 12 months post-procedure
|
0.00%
0/219 • 12 months post-procedure
|
0.00%
0/71 • 12 months post-procedure
|
|
Cardiac disorders
Lead Perforation
|
1.2%
2/165 • Number of events 2 • 12 months post-procedure
|
0.00%
0/219 • 12 months post-procedure
|
0.00%
0/71 • 12 months post-procedure
|
Other adverse events
Adverse event data not reported
Additional Information
Associate Director of Clinical Operations
Aziyo Biologics, Inc.
Phone: 470-514-4085
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place