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CIED Implantation in Low BMI Patients | Clinical Trials | Clareo Health

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WITHDRAWNNANCT04299282

CIED Implantation in Low BMI Patients

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).

Lead sponsor: Elutia Inc.•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Elutia Inc.

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.

Age

All ages

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 16, 2025Terms

Trial snapshot

StatusWITHDRAWN

PhaseNA

Enrollment—

Start dateJun 2021

Last updatedMay 16, 2025

Condition

Heart Diseases Cardiac Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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