CIED Implantation in Low BMI Patients

Study Overview
=================
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.

Official Title
-----------------
A Prospective, Randomized, Single-Center Study Evaluating CanGaroo in Low BMI Patients Undergoing Pacemaker, ICD, or S-ICD Implantation

Conditions
-----------------
Heart Diseases, Cardiac Disease

Intervention / Treatment
-----------------
* Device: CanGaroo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CanGaroo<br>The treatment group will receive a CanGaroo envelope with implantation of a CIED | Device: CanGaroo<br>* CIED ECM envelope<br>|
| No Intervention: No CanGaroo<br>The control group will not receive a CanGaroo envelope with implantation of a CIED | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing at incision site | Improved incision site healing for the CanGaroo group | 3 months post CIED implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL Survey | Patient assessment via Quality of Life Survey | 3 months post CIED implantation | 
| Vascular Tissue Layer | Ultrasound measurement of vascular tissue layer | 3 months post CIED implantation | 
| Skin Fold Test | Skin fold test measurement for tissue thickness | 3 months post CIED implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CIED, Pacemaker, ICD, S-ICD