Cardiac Disease, Heart Diseases
Conditions
Keywords
CIED, Pacemaker, ICD, S-ICD
Brief summary
The primary objective is to demonstrate a better degree of healing at the incision site and a decrease in erosion with CanGaroo compared to control patients (no envelope, CIED alone).
Detailed description
A single-center, prospective, randomized, post-market study of patients undergoing implantation of a pacemaker, ICD, or S-ICD with or without CanGaroo using the same hydration solution. Twenty patients, randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled. Follow-up visits include post-op and 3-months following the implantation procedure.
Interventions
DEVICECanGaroo
CIED ECM envelope
Sponsors
Elutia Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* BMI of less than 23. * Already scheduled for or a clinical decision made to have one of the following qualifying CIED implant procedures using a device cleared by the U.S. FDA: * De novo pacemaker, ICD, or S-ICD; * Upgrade or change out of existing CIED to a pacemaker, ICD, or S-ICD * Clinically stable and able to tolerate procedure. * Be able and willing to return for follow-up care through the 3-month visit. * Must possess the ability to provide informed consent.
Exclusion criteria
* Patients with a known sensitivity to porcine material. * Participation in another clinical study. * Active infection. Clinical diagnosis of an active infection at the time of CIED implant (CIED infection, pneumonia, UTI, endovascular, cellulitis, bacteremia, or other major systemic infection). * Female patient who is pregnant, or planning to become pregnant during the length of the study. * Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis in the past 12 months. * Life expectancy of less than 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing at incision site | 3 months post CIED implantation | Improved incision site healing for the CanGaroo group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QOL Survey | 3 months post CIED implantation | Patient assessment via Quality of Life Survey |
| Vascular Tissue Layer | 3 months post CIED implantation | Ultrasound measurement of vascular tissue layer |
| Skin Fold Test | 3 months post CIED implantation | Skin fold test measurement for tissue thickness |
Outcome results
None listed