MedTrace Logo

Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation

NCT04645173 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2024-01-09

No results posted yet for this study

Summary

The objective of this study is to gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, TYRX™ envelope, or no envelope.

Conditions

  • Cardiac Disease

Interventions

DEVICE

CIED envelope

Evaluation of the difference in cohorts for soft tissue healing surrounding the CIED implant and clinical outcomes and complications.

Sponsors & Collaborators

  • Elutia Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2023-10-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04645173 on ClinicalTrials.gov