Back to resultsCIED Implantation in Low BMI Patients
Primary Purpose
Heart Diseases, Cardiac Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CanGaroo
Sponsored by
About this trial
This is an interventional prevention trial for Heart Diseases focused on measuring CIED, Pacemaker, ICD, S-ICD
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CanGaroo
No CanGaroo
Arm Description
The treatment group will receive a CanGaroo envelope with implantation of a CIED
The control group will not receive a CanGaroo envelope with implantation of a CIED
Outcomes
Primary Outcome Measures
Healing at incision site
Improved incision site healing for the CanGaroo group
Secondary Outcome Measures
QOL Survey
Patient assessment via Quality of Life Survey
Vascular Tissue Layer
Ultrasound measurement of vascular tissue layer
Skin Fold Test
Skin fold test measurement for tissue thickness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04299282
Brief Title
CIED Implantation in Low BMI Patients
Official Title
A Prospective, Randomized, Single-Center Study Evaluating CanGaroo in Low BMI Patients Undergoing Pacemaker, ICD, or S-ICD Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Postponed due to COVID-19 pandemic
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aziyo Biologics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Cardiac Disease
Keywords
CIED, Pacemaker, ICD, S-ICD
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CanGaroo
Arm Type
Active Comparator
Arm Description
The treatment group will receive a CanGaroo envelope with implantation of a CIED
Arm Title
No CanGaroo
Arm Type
No Intervention
Arm Description
The control group will not receive a CanGaroo envelope with implantation of a CIED
Intervention Type
Device
Intervention Name(s)
CanGaroo
Intervention Description
CIED ECM envelope
Primary Outcome Measure Information:
Title
Healing at incision site
Description
Improved incision site healing for the CanGaroo group
Time Frame
3 months post CIED implantation
Secondary Outcome Measure Information:
Title
QOL Survey
Description
Patient assessment via Quality of Life Survey
Time Frame
3 months post CIED implantation
Title
Vascular Tissue Layer
Description
Ultrasound measurement of vascular tissue layer
Time Frame
3 months post CIED implantation
Title
Skin Fold Test
Description
Skin fold test measurement for tissue thickness
Time Frame
3 months post CIED implantation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Riebman, MD, MA
Organizational Affiliation
Aziyo Biologics, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.aziyo.com
Description
Sponsor website
Learn more about this trial
CIED Implantation in Low BMI Patients
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