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NCT04206501 · ClinicalTrials.gov registry record · NA
OptiVol for Precision Medical Management of Heart Failure
A NA study, sponsored by University of Rochester.
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT04206501: Clinical Trial NA study, sponsored by University of Rochester.
NCT04206501 is a NA study that was terminated before completion, run by University of Rochester. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04206501, a NA study, was terminated before completion, sponsored by University of Rochester.
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
This clinical study is designed to show that a multidisciplinary team following a pre-specified standard of care medication decision model based on data from an implanted cardioverter device will increase the rate of change in Guideline Directed Medical Therapy (GDMT) in the intervention group compared to the conventional group in patients with ischemic and non-ischemic cardiomyopathies.
Primary Outcome
The rate of change as measured in the number of medications modified during medical management with beta-blockers, diuretics and sacubitril/Valsartan (defined as initiation, termination, switch, or dosing adjustment) in the intervention group compared to usual care will serve as the primary outcome. The (minimum, maximum) values (0,5) and the range (0 - 5) apply to the rate of change of the prespecified medications. The greater the rate of change, the more optimization (better) the intervention
Interventions
- DEVICE Medtronic ICD with Opti Vol-Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-02-05 |
| Est. Completion | 2022-11-20 |
| Phase | NA |
Why NCT04206501 stopped before completion
NCT04206501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Medtronic ICD with Opti Vol-Monitor is the first listed.
NCT04206501 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04206501 about?
NCT04206501 is a clinical study titled "OptiVol for Precision Medical Management of Heart Failure". This clinical study is designed to show that a multidisciplinary team following a pre-specified standard of care medication decision model based on data from an implanted cardioverter device will increase the rate of change in Guideline Directed Medical Therapy (GDMT) in the intervention group compa...
What is the current status of trial NCT04206501?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2020-02-05. Estimated completion is 2022-11-20.
What interventions are being tested in trial NCT04206501?
The interventions under investigation include: Medtronic ICD with Opti Vol-Monitor (DEVICE).
Who is sponsoring clinical trial NCT04206501?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04206501's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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