Last reviewed · How we verify
NCT04645173: HEAL
Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation
trial testing CIED envelope in Cardiac Disease in 46 participants. Completed in 31 December 2023.
31 October 2023
Quick facts
| Lead sponsor | Elutia Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 46 |
| Start date | 2 February 2021 |
| Primary completion | 31 October 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 11 locations across United States |
Drugs / interventions tested
- CIED envelope
Conditions studied
- Cardiac Disease — all drugs for Cardiac Disease →
Sponsor
Elutia Inc.
Who can join
18 and older, any sex, with Cardiac Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Rehabilitation of an existing device implant pocket using a biologic extracellular matrix envelope.
Srivastava A, Nayak HM. · · 2023 · cited 4× · PMID 38023680 · DOI 10.1016/j.hrcr.2023.08.007 -
Preclinical and clinical evaluation of ECM bioenvelopes for preventing CIED pocket complications.
Catanzaro JN, Christopher TJ, Issa ZF, Nekkanti R, et al · · 2025 · PMID 41019442 · DOI 10.3389/fcvm.2025.1638929
Verify or expand the search:
- PubMed search for NCT04645173
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cardiac Disease
Currently open trials in the same condition.
- NCT07532174 — Efferon LPS Hemoadsorption in Cardiac Surgery Patients · NA · recruiting
- NCT06294119 — Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay · NA · recruiting
- NCT07274436 — The Clinical Value of Deep Learning-Based Reconstruction Techniques in Cardiac MRI Scanning · recruiting
- NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · NA · recruiting
- NCT05877755 — Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging · NA · recruiting
Other Elutia Inc. trials
Trials by the same sponsor.
- NCT04846127 — CanGaroo® Registry Study · completed
- NCT04351269 — Retrospective Experience Of CIED Implantation · completed
- NCT04060134 — A Retrospective Breast Reconstruction Study · completed
- NCT03896347 — A Study Evaluating 3-Level OLIF Spine Fusion · withdrawn
- NCT03425682 — ViBone in Cervical and Lumbar Spine Fusion · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04645173 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Elutia Inc.
- Last refreshed: 9 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04645173.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing