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.
Listed as NCT03102437, this NA trial focuses on CHF and Chronic Heart Disease and remains terminated or withdrawn.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 20 times since 2017, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.
Study Description(click to expand)The Continued Access study is a prospective, non-randomized, multi-center study designed to allow controlled access to the Optimizer Smart System until the PMA order has been issued by the FDA.
The Continued Access study is a prospective, non-randomized, multi-center study designed to allow controlled access to the Optimizer Smart System until the PMA order has been issued by the FDA.
Status Flow
Change History
20 versions recorded-
Jan 2026 — Present [monthly]
Terminated NA
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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
▶ Show 15 earlier versions
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Dec 2021 — Dec 2022 [monthly]
Terminated NA
Status: Completed → Terminated
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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 .