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NCT03361189 · ClinicalTrials.gov registry record · Phase 2
Specialized Pacing for Patients With Congenital Heart Disease
A Phase 2 study, sponsored by University of California, Los Angeles.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT03361189: Clinical Trial Phase 2 study, sponsored by University of California, Los Angeles.
NCT03361189 is a Phase 2 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03361189, a Phase 2 study, was terminated before completion, sponsored by University of California, Los Angeles.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing algorithm has been shown to be highly effective for a wide range of clinical scenarios. Despite the fact that congenital heart disease (CHD) patients are likely to derive significant benefit in terms of functional ability and aerobic capacity using this novel technology, the CLS system has not been adequately studied in this population. As many CHD patients also undergo epicardial placement of pacing systems at the time of concomitant cardiac surgery, CLS has been less often utilized in this population given almost no data in the setting of surgical electrode placement. The present study intends to examine the benefits of the CLS algorithm in the CHD population, employing the use of epicardial pacemaker systems in the study protocol.
Primary Outcome
Heart rate in response to mental stress during each intervention; a math test was performed during autonomic testing
Interventions
- DEVICE Closed loop stimulation
- DEVICE Standard rate response
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-05-09 |
| Est. Completion | 2021-11-03 |
| Phase | Phase 2 |
Why NCT03361189 stopped before completion
NCT03361189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Closed loop stimulation is the first listed.
NCT03361189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03361189 about?
NCT03361189 is a clinical study titled "Specialized Pacing for Patients With Congenital Heart Disease". The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing algorithm has been shown to be highly effective for a wide range of clinical sc...
What is the current status of trial NCT03361189?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2021-05-09. Estimated completion is 2021-11-03.
What interventions are being tested in trial NCT03361189?
The interventions under investigation include: Closed loop stimulation (DEVICE), Standard rate response (DEVICE).
Who is sponsoring clinical trial NCT03361189?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03361189's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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