CIED Implantation in Low BMI Patients

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04299282
• Other study ID #: CPR-2205
• Status: Withdrawn
• Phase: N/A
• Start date: June 2021
• Est. completion date: March 2022

Study information

• Verified date: July 2023
• Source: Aziyo Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Device:
• CanGaroo
CIED ECM envelope

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aziyo Biologics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing at incision site	Improved incision site healing for the CanGaroo group	3 months post CIED implantation
Secondary	QOL Survey	Patient assessment via Quality of Life Survey	3 months post CIED implantation
Secondary	Vascular Tissue Layer	Ultrasound measurement of vascular tissue layer	3 months post CIED implantation
Secondary	Skin Fold Test	Skin fold test measurement for tissue thickness	3 months post CIED implantation

External Links

•   Sponsor website