deltatrials
Completed OBSERVATIONAL NCT01872949

C-Pulse® System European Multicenter Study (OPTIONS-HF)

C-Pulse System eurOPean mulTicenter Study, Implantable cOuNterpulsation System in patIents With Moderate to Severe Heart Failure

Sponsor: Nuwellis, Inc.

Conditions Heart Failure
Updated 11 times since 2017 Last updated: Aug 4, 2023 Started: Jan 13, 2014 Primary completion: May 7, 2018 Completion: Jun 21, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Heart Failure, this trial is completed. The trial is conducted by Nuwellis, Inc. and has accumulated 11 data snapshots since 2014. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotActive Not Recruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshotActive Not Recruiting~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshotActive Not Recruiting~Jan 2019 – ~Jan 2021 · 24 months · monthly snapshotUnknown Status~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotUnknown Status~Oct 2021 – ~Sep 2023 · 23 months · monthly snapshotUnknown Status~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed

  2. Sep 2024 — Sep 2025 [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Sep 2023 — Jul 2024 [monthly]

    Completed

    Status: Unknown StatusCompleted

  5. Oct 2021 — Sep 2023 [monthly]

    Unknown Status

Show 6 earlier versions
  1. Jan 2021 — Oct 2021 [monthly]

    Unknown Status

  2. Jan 2019 — Jan 2021 [monthly]

    Unknown Status

    Status: Active Not RecruitingUnknown Status

  3. Dec 2018 — Jan 2019 [monthly]

    Active Not Recruiting

  4. Jun 2018 — Dec 2018 [monthly]

    Active Not Recruiting

  5. Apr 2018 — Jun 2018 [monthly]

    Active Not Recruiting

    Phase: NANone

  6. Jan 2017 — Apr 2018 [monthly]

    Active Not Recruiting NA

    First recorded

Jan 2014

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Nuwellis, Inc.
Data source: Nuwellis, Inc.

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