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CanGaroo Envelope for Cardiovascular Disease (HEAL Trial)

N/A
Waitlist Available
Research Sponsored by Aziyo Biologics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up surgical procedure visit
Awards & highlights

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.

Eligible Conditions
  • Cardiovascular Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surgical procedure visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and surgical procedure visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blinded Histologic Evaluation of Biopsies Taken from the Anterior and Posterior Capsule Wall
Secondary outcome measures
Documented CIED Complications
Other outcome measures
Assessment of Lead Adhesions within the Implant Pocket
CIED Implant Photographs
CIED Scar Photographs
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: TYRX EnvelopeExperimental Treatment1 Intervention
Participants who received a TYRX envelope during CIED implantation
Group II: No EnvelopeExperimental Treatment0 Interventions
Participants who did not receive an envelope during CIED implantation
Group III: CanGaroo EnvelopeExperimental Treatment1 Intervention
Participants who received a CanGaroo envelope during CIED implantation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CIED envelope
2021
N/A
~50

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Who is running the clinical trial?

Aziyo Biologics, Inc.Lead Sponsor
12 Previous Clinical Trials
4,567 Total Patients Enrolled
~10 spots leftby Sep 2025
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