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Novel Cardiac Signal Processing System
NCT04112433 · View on ClinicalTrials.gov ↗
Study Summary
This study is designed to collect parallel intracardiac signal data during pre-defined periods of clinical interest from the PURE EP system and the existing signal recording and mapping systems. The collected signals will then undergo BLINDED, CONTROLLED evaluation by unbiased electrophysiologist reviewer(s) to determine whether the PURE EP signals provides additional or clearer diagnostic information.
Conditions Studied
Interventions
- DEVICE PURE EP 2
Study Locations (3)
Florida
- Mayo Clinic Jacksonville — Jacksonville
Massachusetts
- Massachusetts General Hospital — Boston
Texas
- St. David's Medical Center — Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2019-11-12 |
| Est. Completion | 2022-01-29 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04112433
The ClinicalTrials.gov registry entry for NCT04112433 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioSig Technologies, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cardiac Arrhythmia appearing as the primary indexed condition, and to 1 intervention — of which PURE EP 2 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04112433 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Florida, Massachusetts, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04112433 about?
NCT04112433 is a clinical study titled "Novel Cardiac Signal Processing System". This study is designed to collect parallel intracardiac signal data during pre-defined periods of clinical interest from the PURE EP system and the existing signal recording and mapping systems. The collected signals will then undergo BLINDED, CONTROLLED evaluation by unbiased electrophysiologist r...
What is the current status of trial NCT04112433?
This trial is currently completed. The enrollment target is 104 participants. The study started on 2019-11-12. Estimated completion is 2022-01-29.
What conditions does trial NCT04112433 study?
This clinical trial studies the following conditions: Cardiac Arrhythmia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04112433?
The interventions under investigation include: PURE EP 2 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04112433?
This trial is sponsored by BioSig Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04112433 being conducted?
This trial has 3 study locations across Florida, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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