CIED Implantation in Low BMI Patients

Not Applicable

Withdrawn

• Conditions: Heart Diseases; Cardiac Disease
• Interventions: Device: CanGaroo

• Registration Number: NCT04299282
• Lead Sponsor: Elutia 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).

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 Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-06
• Study Start: 2021-06
• Primary Completion: 2021-12
• Study Completion: 2022-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Healing at incision site	3 months post CIED implantation	Improved incision site healing for the CanGaroo group

Secondary Outcome Measures

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