CIED Implantation in Low BMI Patients

Elutia Inc.

Status

Withdrawn

Conditions

Cardiac Disease

Heart Diseases

Treatments

Device: CanGaroo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04299282

CPR-2205

Details and patient eligibility

About

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).

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

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.