CIED Implantation in Low BMI Patients

July 19, 2023 updated by: Aziyo Biologics, Inc.

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aziyo Biologics, Inc.

Investigators

  • Study Director: Jerry Riebman, MD, MA, Aziyo Biologics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2021

Primary Completion (Estimated)

December 1, 2021

Study Completion (Estimated)

March 1, 2022

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPR-2205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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