Trial Outcomes & Findings for A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) Envelope (NCT NCT02530970)
NCT ID: NCT02530970
Last Updated: 2023-07-21
Results Overview
ECM related adverse events were collected at all study visits.
Recruitment status
COMPLETED
Target enrollment
1025 participants
Primary outcome timeframe
Participants were followed for an average of 235.0 days.
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
CanGaroo
Data collection for information on the use of CorMatrix CanGaroo ECM Envelope
|
|---|---|
|
Overall Study
STARTED
|
1025
|
|
Overall Study
COMPLETED
|
891
|
|
Overall Study
NOT COMPLETED
|
134
|
Reasons for withdrawal
| Measure |
CanGaroo
Data collection for information on the use of CorMatrix CanGaroo ECM Envelope
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Lost to Follow-up
|
88
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Death
|
6
|
|
Overall Study
Hospitalization
|
1
|
|
Overall Study
Insurance
|
2
|
|
Overall Study
Explant
|
2
|
|
Overall Study
Change in Provider
|
5
|
|
Overall Study
Relocation
|
3
|
Baseline Characteristics
A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) Envelope
Baseline characteristics by cohort
| Measure |
CanGaroo
n=1025 Participants
Data collection for information on the use of CorMatrix CanGaroo ECM Envelope
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
257 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
768 Participants
n=99 Participants
|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
392 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
633 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
990 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
175 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
797 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
1025 participants
n=99 Participants
|
|
Risk Factors for Infection
None
|
103 Participants
n=99 Participants
|
|
Risk Factors for Infection
Systemic Anticoagulants
|
233 Participants
n=99 Participants
|
|
Risk Factors for Infection
Chronic Steroid Use
|
14 Participants
n=99 Participants
|
|
Risk Factors for Infection
Renal Insufficiency
|
115 Participants
n=99 Participants
|
|
Risk Factors for Infection
Diabetes
|
301 Participants
n=99 Participants
|
|
Risk Factors for Infection
Prior Device Infection
|
18 Participants
n=99 Participants
|
|
Risk Factors for Infection
Peripheral Vascular Disease
|
80 Participants
n=99 Participants
|
|
Risk Factors for Infection
Pocket Re-entry
|
5 Participants
n=99 Participants
|
|
Risk Factors for Infection
Obesity
|
387 Participants
n=99 Participants
|
|
Risk Factors for Infection
Malnutrition
|
12 Participants
n=99 Participants
|
|
Risk Factors for Infection
Smoker
|
121 Participants
n=99 Participants
|
|
Risk Factors for Infection
Congestive Heart Failure
|
450 Participants
n=99 Participants
|
|
Risk Factors for Infection
Malignancy
|
42 Participants
n=99 Participants
|
|
Risk Factors for Infection
3 or More Leads
|
28 Participants
n=99 Participants
|
|
Risk Factors for Infection
2 or More Risk Factors
|
678 Participants
n=99 Participants
|
|
Risk Factors for Infection
Other
|
180 Participants
n=99 Participants
|
|
Risk Factors for Infection
Temporary Pacing
|
68 Participants
n=99 Participants
|
|
Risk Factors for Infection
Device Replacement/Revision
|
377 Participants
n=99 Participants
|
|
IV Antibiotic Used Prior to Procedure
Yes
|
938 Participants
n=99 Participants
|
|
IV Antibiotic Used Prior to Procedure
Unknown
|
50 Participants
n=99 Participants
|
|
IV Antibiotic Used Prior to Procedure
No
|
37 Participants
n=99 Participants
|
|
Pre-Procedure Temporary Pacing
No
|
823 Participants
n=99 Participants
|
|
Pre-Procedure Temporary Pacing
Unknown
|
134 Participants
n=99 Participants
|
|
Pre-Procedure Temporary Pacing
Yes
|
68 Participants
n=99 Participants
|
|
Surgical Glue Used in Procedure
No
|
677 Participants
n=99 Participants
|
|
Surgical Glue Used in Procedure
Yes
|
321 Participants
n=99 Participants
|
|
Surgical Glue Used in Procedure
Unknown
|
27 Participants
n=99 Participants
|
|
Procedure Types
De Novo Pacemaker
|
324 Participants
n=99 Participants
|
|
Procedure Types
De Novo ICD
|
158 Participants
n=99 Participants
|
|
Procedure Types
De Novo CRT-P
|
27 Participants
n=99 Participants
|
|
Procedure Types
De Novo CRT-D
|
93 Participants
n=99 Participants
|
|
Procedure Types
Pacemaker Replacement
|
122 Participants
n=99 Participants
|
|
Procedure Types
ICD Replacement
|
71 Participants
n=99 Participants
|
|
Procedure Types
CRT-P Replacement
|
4 Participants
n=99 Participants
|
|
Procedure Types
CRT-D Replacement
|
71 Participants
n=99 Participants
|
|
Procedure Types
Upgrade Pacemaker to ICD
|
13 Participants
n=99 Participants
|
|
Procedure Types
Upgrade Pacemaker to CRT-P
|
21 Participants
n=99 Participants
|
|
Procedure Types
Upgrade Pacemaker to CRT-D
|
27 Participants
n=99 Participants
|
|
Procedure Types
Upgrade ICD to CRT-D
|
47 Participants
n=99 Participants
|
|
Procedure Types
Downgrad CRT-D to ICD
|
1 Participants
n=99 Participants
|
|
Procedure Types
Lead Revision/Replacement Only
|
36 Participants
n=99 Participants
|
|
Procedure Types
Pocket Revision Only
|
10 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for an average of 235.0 days.Population: Analysis population includes all study participants.
ECM related adverse events were collected at all study visits.
Outcome measures
| Measure |
CanGaroo
n=1025 Participants
Arm/group includes all study participants.
|
|---|---|
|
Proportion of Subjects With ECM Related Adverse Events
Probably Related to CanGaroo
|
2 Participants
|
|
Proportion of Subjects With ECM Related Adverse Events
Possibly Related to CanGaroo
|
14 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for an average of 235.0 days.Population: Analysis population includes all study participants.
Incidence of major pocket infection included those with cellulitis in the region of the CIED pocket with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space (pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis.
Outcome measures
| Measure |
CanGaroo
n=1025 Participants
Arm/group includes all study participants.
|
|---|---|
|
Number of Participants With Major Pocket Infections
|
12 Participants
|
Adverse Events
CanGaroo
Serious events: 40 serious events
Other events: 0 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
CanGaroo
n=1025 participants at risk
Data collection for information on the use of CorMatrix CanGaroo ECM Envelope
|
|---|---|
|
General disorders
Pain
|
0.49%
5/1025 • Number of events 5 • Participants will be followed for an expected average of 3 months
|
|
Cardiac disorders
Heart Failure
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Cardiac disorders
Syncope
|
0.20%
2/1025 • Number of events 2 • Participants will be followed for an expected average of 3 months
|
|
Skin and subcutaneous tissue disorders
Superficial Cellulitis
|
0.20%
2/1025 • Number of events 2 • Participants will be followed for an expected average of 3 months
|
|
Surgical and medical procedures
Pocket Erosion
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Infections and infestations
Pocket Infection
|
1.2%
12/1025 • Number of events 12 • Participants will be followed for an expected average of 3 months
|
|
Vascular disorders
Hematoma
|
0.49%
5/1025 • Number of events 6 • Participants will be followed for an expected average of 3 months
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
0.20%
2/1025 • Number of events 2 • Participants will be followed for an expected average of 3 months
|
|
Surgical and medical procedures
Lead Issues
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Surgical and medical procedures
Inappropriate ICD Shocks
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Cardiac disorders
Palpitations & Shortness of Breath
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Cardiac disorders
Congestive Heart Failure/Renal Failure
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Infections and infestations
Superficial CIED Infection
|
0.20%
2/1025 • Number of events 2 • Participants will be followed for an expected average of 3 months
|
|
Psychiatric disorders
Suicidal Ideation
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Cardiac disorders
Tachycardia
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Cardiac disorders
NSTEMI
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Cardiac disorders
Seroma
|
0.10%
1/1025 • Number of events 1 • Participants will be followed for an expected average of 3 months
|
|
Cardiac disorders
Congestive Heart Failure
|
0.20%
2/1025 • Number of events 2 • Participants will be followed for an expected average of 3 months
|
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: GT60