Cardiac ArrhythmiaNCT04112433
Novel Cardiac Signal Processing System
An observational study of Cardiac Arrhythmia, run by BioSig Technologies, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- PURE EP 2
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Nov 2019to 29 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any person indicated and consented for an elective cardiac ablation procedure who is >18 years of age.
Who may be able to join
- Indication for cardiac ablation treatment
- Signed informed consent
Who cannot join
- contraindication to electrophysiology study or ablation
- Enrollment in any other ongoing arrhythmia study protocol
- Active Infection or sepsis
- Pregnancy or lactation
- < 18 years of age
Trial locations and contacts
3 sites in 1 country.
United States3 sites
St. David's Medical Center
Austin, Texas, 78758
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
About this study
Official title: Novel Cardiac Signal Processing System for Electrophysiology Procedures
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.
Read the detailed description
Cardiac electrophysiologists rely on the display of electrograms when performing electrophysiology (EP) studies and catheter ablations in patients with arrhythmias. To achieve effective outcomes without complications, it is vital that the recording system enables the recognition of clearly abnormal (scared myocardium) and normal electrical signals.
Current recording systems have limitations in that it can be difficult to clearly distinguish a true cardiac signal from noise or artifact. This is particularly true when pacing the heart and when ablating abnormal myocardial tissue, components of the conduction system or epicardial structures. Therefore, improvement of the fidelity of signals obtained from EP recording systems is needed to enhance identification of the most effective targets for ablation.
There are several standard electrophysiology recording systems in use today, such as the commonly used GE/Prucka CardioLab recording system ("Prucka") which would benefit from additional features in order to improve the ability to record, discriminate and analyze signals from the heart. BioSig Technologies, Inc. ("BioSig") has developed an electrophysiology signal processing system, the PURE EP™ System, which may allow electrophysiologists to better characterize arrhythmogenic tissue during ablation procedures. Specifically, the PURE EP™ System's higher sampling rate and higher dynamic range allow improved visualization of low amplitude signals, especially those temporally situated near low frequency, high amplitude signals or large high-frequency signals.
This multi-center, prospective, non-randomized, observational study will involve at least five patients undergoing elective cardiac ablation procedure for tachycardias such as atrial fibrillation, atypical atrial flutter, ischemic ventricular tachycardia, or symptomatic premature ventricular contractions (PVCs). The existing recording/mapping system clocks will be synchronized to the PURE EP clock prior to each procedure. At the beginning of the procedures, all systems will be optimized for best signal display based on the physician preference. During the ablation procedures, annotations will be captured on the PURE EP system based on pre-determined clinically relevant events defined in this protocol (example - before and after successful ablation therapy).
After the procedures, parallel signal data samples will be harvested from all the systems using the procedure annotations and the time stamps as a guide. Once the signal data is harvested, cleaned, and organized, the individual signal samples will be reviewed in a blinded, controlled fashion by a group of independent, unbiased electrophysiologist(s).
Selected signal sample sets (from the same date and time stamp) will be separated in the survey and arranged in random order. The reviewer will be asked specific and identical questions relevant to each set of signal samples, but the individual samples will be separated and randomized across a full survey containing many different signal samples from many different procedures. The signal survey will be created under the direction of the Principle Investigator. The selection of the independent EP reviewers will also be done under the direction of the Principle Investigator
- Conditions
- Cardiac Arrhythmia
- Being tested
- PURE EP 2
- Keywords
- Cardiac Signal, Ablation, Signal Processing, Intracardiac Electrogram, Electrophysiology, Electrogram, Signals, Cardiac, Cardiac Ablation, Atrial fibrillation, Atrial Flutter, Ventricular Tachycardia, Arrhythmias, PVC's
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PURE EP 2Device
Enrolled patients receiving cardiac ablation treatment using the current standard of care with additional monitoring and intracardiac electrogram signal collection via the PURE EP 2 system.
| Study group | Role | What they receive |
|---|---|---|
| PURE EP 2 Group | Enrolled and consented patients who are indicated for and receive an elective cardiac ablation procedure using the PURE EP 2 system for monitoring and collection of intracardiac electrogram signals. Receives: Device: PURE EP 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe and effective use of the PURE EP 2 system based on system specifications and recorded within the Case Report Form (CRF).
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 PURE EP system will be redundant.
The intracardiac signals from the PURE EP system will be compared to existing recording and mapping system signals generated in real-time during each ablation procedure. The PURE EP system signals will be monitored by the physician investigator and a company clinical representative to validate the PURE EP 2 system runs as intended based on the system manual and meets expected standards for displaying signals.
Measured: Throughout the cardiac ablation procedure
Secondary outcomes (1)
Assess the quality of the PURE EP 2 intracardiac signals when compared to existing recording and mapping systems as determined by controlled survey of blinded, independent expert electrophysiology reviewers.
The secondary aim of this study is to assess the quality of the PURE EP intracardiac signals and the associated clinical relevance of the signals when compared to other sources of intracardiac signals. During the ablation procedures, annotations will be captured on the PURE EP system based on clinically relevant events defined in the protocol.
After the procedure, parallel signal data samples will be harvested from all the systems using annotations and the time stamps as a guide. Once the signal data is harvested and organized, the signal samples across multiple procedures will be reviewed in a blinded, controlled fashion by 2-3 independent, unbiased expert electrophysiologist(s).
The sample survey will be created under the direction of the PI.
Measured: After the collection of signal samples from at least (5) subjects and until study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start12 Nov 2019
- Primary completion20 Jul 2021
- Study completion29 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioSig Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112433
- Sponsor's protocol ID
- PURE EP 2.0
- Status last verified
- Feb 2022
- First submitted
- 30 Sep 2019
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Collected intracardiac signal samples will be shared with the independent electrophysiologist reviewers, other physician investigators, and possibly other study collaborators like a biostatistician and clinical research organization.
Publications
Padmanabhan D, Sugrue A, Vaidya V, Witt C, Yasin O, Naksuk N, Killu A, Foxall T, Drakulic BS, Venkatachalam KL, Asirvatham SJ. Incremental benefit of a novel signal recording system during mapping and ablation. Europace. 2021 Jan 27;23(1):130-138. doi: 10.1093/europace/euaa194.
PubMed 33094311
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Cardiac Signal Processing System for Electrophysiology Procedures
- ClinicalTrials.gov ID
- NCT04112433
- Acronym / sponsor ID
- PURE EP 2.0
- Conditions
- Cardiac Arrhythmia
- Keywords
- Cardiac Signal, Ablation, Signal Processing, Intracardiac Electrogram, Electrophysiology, Electrogram, Signals, Cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- BioSig Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 29 Jan 2022 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiac electrophysiologists rely on the display of electrograms when performing electrophysiology (EP) studies and catheter ablations in patients with arrhythmias. To achieve effective outcomes without complications, it is vital that the recording system enables the recognition of clearly abnormal (scared myocardium) and normal electrical signals.
Current recording systems have limitations in that it can be difficult to clearly distinguish a true cardiac signal from noise or artifact. This is particularly true when pacing the heart and when ablating abnormal myocardial tissue, components of the conduction system or epicardial structures. Therefore, improvement of the fidelity of signals obtained from EP recording systems is needed to enhance identification of the most effective targets for ablation.
There are several standard electrophysiology recording systems in use today, such as the commonly used GE/Prucka CardioLab recording system ("Prucka") which would benefit from additional features in order to improve the ability to record, discriminate and analyze signals from the heart. BioSig Technologies, Inc. ("BioSig") has developed an electrophysiology signal processing system, the PURE EP™ System, which may allow electrophysiologists to better characterize arrhythmogenic tissue during ablation procedures. Specifically, the PURE EP™ System's higher sampling rate and higher dynamic range allow improved visualization of low amplitude signals, especially those temporally situated near low frequency, high amplitude signals or large high-frequency signals.
This multi-center, prospective, non-randomized, observational study will involve at least five patients undergoing elective cardiac ablation procedure for tachycardias such as atrial fibrillation, atypical atrial flutter, ischemic ventricular tachycardia, or symptomatic premature ventricular contractions (PVCs). The existing recording/mapping system clocks will be synchronized to the PURE EP clock prior to each procedure. At the beginning of the procedures, all systems will be optimized for best signal display based on the physician preference. During the ablation procedures, annotations will be captured on the PURE EP system based on pre-determined clinically relevant events defined in this protocol (example - before and after successful ablation therapy).
After the procedures, parallel signal data samples will be harvested from all the systems using the procedure annotations and the time stamps as a guide. Once the signal data is harvested, cleaned, and organized, the individual signal samples will be reviewed in a blinded, controlled fashion by a group of independent, unbiased electrophysiologist(s).
Selected signal sample sets (from the same date and time stamp) will be separated in the survey and arranged in random order. The reviewer will be asked specific and identical questions relevant to each set of signal samples, but the individual samples will be separated and randomized across a full survey containing many different signal samples from many different procedures. The signal survey will be created under the direction of the Principle Investigator. The selection of the independent EP reviewers will also be done under the direction of the Principle Investigator
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PURE EP 2 Group | – | Device: PURE EP 2Enrolled and consented patients who are indicated for and receive an elective cardiac ablation procedure using the PURE EP 2 system for monitoring and collection of intracardiac electrogram signals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any person indicated and consented for an elective cardiac ablation procedure who is >18 years of age.
Key inclusion criteria (2 listed)
- Indication for cardiac ablation treatment
- Signed informed consent
Key exclusion criteria (5 listed)
- contraindication to electrophysiology study or ablation
- Enrollment in any other ongoing arrhythmia study protocol
- Active Infection or sepsis
- Pregnancy or lactation
- < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PURE EP 2Enrolled patients receiving cardiac ablation treatment using the current standard of care with additional monitoring and intracardiac electrogram signal collection via the PURE EP 2 system. | Device | PURE EP 2 Group |
Primary outcome
Safe and effective use of the PURE EP 2 system based on system specifications and recorded within the Case Report Form (CRF).
Time frame: Throughout the cardiac ablation procedure
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 PURE EP system will be redundant. The intracardiac signals from the PURE EP system will be compared to existing recording and mapping system signals generated in real-time during each ablation procedure. The PURE EP system signals will be monitored by the physician investigator and a company clinical representative to validate the PURE EP 2 system runs as intended based on the system manual and meets expected standards for displaying signals.
1 secondary outcome
Assess the quality of the PURE EP 2 intracardiac signals when compared to existing recording and mapping systems as determined by controlled survey of blinded, independent expert electrophysiology reviewers.
Time frame: After the collection of signal samples from at least (5) subjects and until study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Derived from this study: PubMed 33094311Padmanabhan D, Sugrue A, Vaidya V, Witt C, Yasin O, Naksuk N, Killu A, Foxall T, Drakulic BS, Venkatachalam KL, Asirvatham SJ. Incremental benefit of a novel signal recording system during mapping and ablation. Europace. 2021 Jan 27;23(1):130-138. doi: 10.1093/europace/euaa194.
- Individual participant dataSharing planned: Undecided. Collected intracardiac signal samples will be shared with the independent electrophysiologist reviewers, other physician investigators, and possibly other study collaborators like a biostatistician and clinical research organization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by BioSig Technologies, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safe and effective use of the PURE EP 2 system based on system specifications and recorded within the Case Report Form (CRF). (time frame: Throughout the cardiac ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04112433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.