CIED Implantation in Low BMI Patients

NCT04299282 | Withdrawn FDA Device

• 1 other identifier: CPR-2205
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Heart Diseases; Cardiac Disease

Keywords

CIED, Pacemaker, ICD, S-ICD

Outcome Measures

Primary Outcomes (1)

• Healing at incision site

  Improved incision site healing for the CanGaroo group

  3 months post CIED implantation

Secondary Outcomes (3)

• QOL Survey

  3 months post CIED implantation

• Vascular Tissue Layer

  3 months post CIED implantation

• Skin Fold Test

  3 months post CIED implantation

Study Arms (2)

CanGaroo

ACTIVE COMPARATOR

The treatment group will receive a CanGaroo envelope with implantation of a CIED

Device: CanGaroo

No CanGaroo

NO INTERVENTION

The control group will not receive a CanGaroo envelope with implantation of a CIED

Interventions

CanGaroo DEVICE

CIED ECM envelope

CanGaroo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elutia Inc.: lead

Related Links

• Sponsor website

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Jerry Riebman, MD, MA

  Elutia Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 6, 2020
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share