deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02809131

Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections. (ENVELOPE)

Randomized Noninferiority Study of an Antibacterial Envelope Alone Versus Envelope Plus Intraoperative Antibacterial Irrigant and Postoperative Antibiotics to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Patients

Sponsor: Medtronic

Conditions Chronic Systolic Heart Failure Complete Heart Block Sick Sinus Syndrome Syncope
Interventions Saline cephalexin, or levofloxacin, or clindamycin polymixin/bacitracin
Updated 13 times since 2017 Last updated: Apr 13, 2022 Started: Apr 1, 2016 Primary completion: Mar 31, 2021 Completion: Sep 30, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Chronic Systolic Heart Failure and Complete Heart Block and is currently completed. Medtronic leads this study, which shows 13 recorded versions since 2016 — indicating substantial longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jun 2018 · 14 months · monthly snapshot~Jun 2018 – ~May 2019 · 11 months · monthly snapshot~May 2019 – ~Aug 2019 · 3 months · monthly snapshot~Aug 2019 – ~Sep 2020 · 13 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Feb 2022 · 5 months · monthly snapshot~Feb 2022 – ~Jun 2022 · 4 months · monthly snapshot~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

13 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jun 2022 — Jul 2024 [monthly]

    Completed PHASE3

  4. Feb 2022 — Jun 2022 [monthly]

    Completed PHASE3

    Status: Recruiting → Completed

  5. Sep 2021 — Feb 2022 [monthly]

    Recruiting PHASE3

▶ Show 8 earlier versions

  1. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  2. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  3. Aug 2019 — Sep 2020 [monthly]

    Recruiting PHASE3

  4. May 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  5. Jun 2018 — May 2019 [monthly]

    Recruiting PHASE3

  6. Apr 2017 — Jun 2018 [monthly]

    Recruiting PHASE3

  7. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  8. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Apr 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Medtronic
  • The Cooper Health System
  • Thomas Jefferson University
  • Valley Health System
  • Vanderbilt University Medical Center
Data source: Vanderbilt University Medical Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations