Status:
WITHDRAWN
CIED Implantation in Low BMI Patients
Lead Sponsor:
Elutia Inc.
Conditions:
Heart Diseases
Cardiac Disease
Eligibility:
All Genders
Phase:
NA
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04299282
Start Date
June 1 2021
End Date
March 1 2022
Last Update
May 16 2025
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