Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04112433 · ClinicalTrials.gov registry record
Novel Cardiac Signal Processing System
A clinical trial of Cardiac Arrhythmia, sponsored by BioSig Technologies.
- Completed
- Registry status
- 104
- Enrollment target
- 3
- Study locations
NCT04112433: Completed study of Cardiac Arrhythmia, sponsored by BioSig Technologies.
NCT04112433 is a study of Cardiac Arrhythmia that has completed, run by BioSig Technologies. The registered enrollment target is 104 participants, below the 205-participant average among 12 other Cardiac Arrhythmia trials with a reported enrollment target (49% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04112433, a study of Cardiac Arrhythmia, has completed, sponsored by BioSig Technologies.
- COMPLETED
- Registry status
- 104 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
The primary aim of this study is to further establish the safe and effective use of the PURE EP System during cardiac ablation in the EP Laboratory in a post-market environment. The PURE EP System will be installed to run in parallel to existing mapping and recording systems already in use in the EP lab. Each system will be optimized for viewing intracardiac signals based on the physician preference. The existing systems will serve as the primary method of viewing intracardiac signals and the PU
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 |
What the finished NCT04112433 record still lists
NCT04112433 is an observational study that tracks outcomes without assigning an intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 205-participant average among 12 other Cardiac Arrhythmia trials with a reported enrollment target (49% lower).
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.
NCT04112433 reports a single indexed study location in Florida, Massachusetts, Texas.
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.
What interventions are being tested in trial NCT04112433?
The interventions under investigation include: PURE EP 2 (DEVICE).
Who is sponsoring clinical trial NCT04112433?
This trial is sponsored by BioSig Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Cardiac Arrhythmia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04112433's enrollment target sits among peer trials
104 6th of 12 higher than 7 of 12 other Cardiac Arrhythmia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiac Arrhythmia 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
-
Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study
ACTIVE NOT RECRUITING
-
Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II
ACTIVE NOT RECRUITING · NA
-
AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals
COMPLETED · NA
-
EnSite Precision Observational Study
COMPLETED
-
Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation
COMPLETED · NA
-
Measuring Hydration Levels of Healthy and Heart Failure Patients Before, During, and After an Electrophysiology (EP) Procedure
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03403686 · 104 participants
Liver X Receptor (LXR) as a Novel Therapeutic Target in Diabetic Retinopathy (DR)
- NCT04228367 · 104 participants · NA
JuggerStitch Post Market Clinical Follow-up Study
- NCT04268849 · 104 participants · Phase 3
Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
- NCT04390724 · 104 participants
Optimizing Y90 Therapy for Radiation Lobectomy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI