Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System (FIX-HF-5CA)
FIX-HF-5CA: Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%
Sponsor: Impulse Dynamics
Terminated
The primary objective of the protocol was to allow ongoing access to treatment of patients suffering from moderate to severe heart failure at selected investigational sites until the PMA was approved by the FDA for the OPTIMIZER System.
Other terminated trials from Impulse Dynamics
Listed as NCT03102437, this NA trial focuses on CHF and Chronic Heart Disease and remains terminated or withdrawn. Sponsored by Impulse Dynamics, it has been updated 19 times since 2017, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.
Status Flow
Change History
19 versions recorded-
Sep 2024 — Present [monthly]
Terminated NA
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Jul 2024 — Sep 2024 [monthly]
Terminated NA
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Jan 2023 — Jul 2024 [monthly]
Terminated NA
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Dec 2022 — Jan 2023 [monthly]
Terminated NA
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Dec 2021 — Dec 2022 [monthly]
Terminated NA
Status: Completed → Terminated
▶ Show 14 earlier versions
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Jan 2021 — Dec 2021 [monthly]
Completed NA
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Feb 2020 — Jan 2021 [monthly]
Completed NA
Status: Recruiting → Completed
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Jul 2019 — Feb 2020 [monthly]
Recruiting NA
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May 2019 — Jul 2019 [monthly]
Recruiting NA
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Feb 2019 — May 2019 [monthly]
Recruiting NA
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Sep 2018 — Feb 2019 [monthly]
Recruiting NA
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Jul 2018 — Sep 2018 [monthly]
Recruiting NA
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Jun 2018 — Jul 2018 [monthly]
Recruiting NA
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May 2018 — Jun 2018 [monthly]
Recruiting NA
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Jan 2018 — May 2018 [monthly]
Recruiting NA
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Dec 2017 — Jan 2018 [monthly]
Recruiting NA
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Oct 2017 — Dec 2017 [monthly]
Recruiting NA
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Aug 2017 — Oct 2017 [monthly]
Recruiting NA
Status: Not Yet Recruiting → Recruiting
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May 2017 — Aug 2017 [monthly]
Not Yet Recruiting NA
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Impulse Dynamics
For direct contact, visit the study record on ClinicalTrials.gov .