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CIED Implantation in Low BMI Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04299282
Recruitment Status : Withdrawn (Postponed due to COVID-19 pandemic)
First Posted : March 6, 2020
Last Update Posted : May 11, 2020
Information provided by (Responsible Party):
Aziyo Biologics, Inc.

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).

Condition or disease Intervention/treatment Phase
Heart Diseases Cardiac Disease Device: CanGaroo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Single-Center Study Evaluating CanGaroo in Low BMI Patients Undergoing Pacemaker, ICD, or S-ICD Implantation
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Active Comparator: CanGaroo
The treatment group will receive a CanGaroo envelope with implantation of a CIED
Device: CanGaroo
CIED ECM envelope

No Intervention: No CanGaroo
The control group will not receive a CanGaroo envelope with implantation of a CIED

Primary Outcome Measures :
  1. Healing at incision site [ Time Frame: 3 months post CIED implantation ]
    Improved incision site healing for the CanGaroo group

Secondary Outcome Measures :
  1. QOL Survey [ Time Frame: 3 months post CIED implantation ]
    Patient assessment via Quality of Life Survey

  2. Vascular Tissue Layer [ Time Frame: 3 months post CIED implantation ]
    Ultrasound measurement of vascular tissue layer

  3. Skin Fold Test [ Time Frame: 3 months post CIED implantation ]
    Skin fold test measurement for tissue thickness

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04299282

Sponsors and Collaborators
Aziyo Biologics, Inc.
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Study Director: Jerry Riebman, MD, MA Aziyo Biologics, Inc.
Additional Information:
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Responsible Party: Aziyo Biologics, Inc. Identifier: NCT04299282    
Other Study ID Numbers: CPR-2205
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Aziyo Biologics, Inc.:
CIED, Pacemaker, ICD, S-ICD
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases