deltatrials
Completed OBSERVATIONAL NCT00996086

Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT) (BENEFIT)

Risk Stratification and Benefits With Cardiac Resynchronization Therapy

Sponsor: Abbott Medical Devices

Interventions CRT device implant
Updated 13 times since 2017 Last updated: Feb 1, 2019 Started: Feb 28, 2010 Primary completion: Sep 30, 2012 Completion: Sep 30, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00996086, this observational or N/A phase trial focuses on Heart Failure and Ventricular Arrhythmias and remains completed. Sponsored by Abbott Medical Devices, it has been updated 13 times since 2010, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Study Description(click to expand)

The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated. This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.

The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated.

This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshot~Aug 2017 – ~Apr 2018 · 8 months · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Nov 2020 · 20 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 19 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

13 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2024 — Present [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Dec 2021 — Jul 2024 [monthly]

    Completed

  5. Jan 2021 — Dec 2021 [monthly]

    Completed

Show 8 earlier versions
  1. Nov 2020 — Jan 2021 [monthly]

    Completed

  2. Mar 2019 — Nov 2020 [monthly]

    Completed

  3. Feb 2019 — Mar 2019 [monthly]

    Completed

  4. Jun 2018 — Feb 2019 [monthly]

    Completed

  5. May 2018 — Jun 2018 [monthly]

    Completed

  6. Apr 2018 — May 2018 [monthly]

    Completed

    Phase: NANone

  7. Aug 2017 — Apr 2018 [monthly]

    Completed NA

  8. Jan 2017 — Aug 2017 [monthly]

    Completed NA

    First recorded

Feb 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Abbott Medical Devices
  • Northwestern University
  • VA Pittsburgh Healthcare System
Data source: Abbott Medical Devices

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