Atrial Fibrillation RecurrentNCT04964440
Redo AF Sub Study (of the Pure EP 2.0 Main Study)
An observational study of Atrial Fibrillation Recurrent, run by BioSig Technologies, Inc. at 1 site in United States.
Trial summary
This study is a sub study of the Pure EP 2.0 trial. In a redo atrial fibrillation population, this study is designed to collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of interest during a redo ablation procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Recurrent
- What is being tested?
- Pure-EP
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to 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
- Adult, Older adult
Study population: Atrial Fibrillation
Who may be able to join
- Patients undergoing scheduled elective cardiac ablation procedures who have signed an informed consent
- Patients who are > 18 years of age.
- Patients undergoing a repeat elective cardiac AF Procedure
Who cannot join
- A complex arrhythmia secondary to a reversible cause
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- Any cardiac surgery within the past 60 days (2 months) (includes PCI)
- Concurrent enrollment in a study evaluating another device or drug
- A complex arrhythmia secondary to electrolyte imbalance, thyroid disease or non-cardiac issue
- Presence of intra-cardiac thrombus or myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation.
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- Presence of a condition that precludes vascular access.
- Women of child baring potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation.
- Active illness or active systemic infection or sepsis.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a sub study of the Pure EP 2.0 trial. In a redo atrial fibrillation population, this study is designed to collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of interest during a redo ablation procedure. These signals are later evaluated for clinical relevance and impact on the procedure.
Read the detailed description
Cardiac electrophysiologists rely on the display of electrograms when performing 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.
In a redo Atrial Fibrillation (AF) procedure, the patient had previously undergone an AF ablation procedure, but is still having AF episodes, which can be life threatening and have been shown to lead to strokes. Since the original AF procedure involved burning or freezing of myocardial tissue, this is now additional scar tissue and may cause more complex electrograms and intracardiac signals.
In this sub study, both the PURE EP™ system and the GE Cardiolab system will be running and recording signals during the entire procedure, with one of the systems displayed on the screen in the procedure room to guide the physician's decision-making. Even numbered subjects will be PURE EP™ guided and odd numbered subjected will be GE CardioLab guided. All other aspects of the procedure will proceed per standard of care. The study will be collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of interest during a redo ablation procedure.
After the physician has completed ablation treatment, matching signals of interest will be extracted from both the PURE EP™ system and the GE Cardiolab recording system as described in the main study. At a later date, a blinded electrophysiologist reviewer will evaluate the signals from both systems with a focus on tissue viability signals and the impact on the procedure. The survey results will then be compared to see the differences in clinical procedure decision-making based on the signal samples.
- Conditions
- Atrial Fibrillation Recurrent
- Being tested
- Pure-EP
- Keywords
- reoccurring, repeat, revision, redo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure-EPDevice
Advanced Signal Acquisition and Processing
| Study group | Role | What they receive |
|---|---|---|
| PURE EP Guided Procedures | Redo AF procedures guided by Pure EP System during an AF Ablation Receives: Device: Pure-EP | |
| Standard Recording System Guided Procedures | Redo AF procedures guided by the Standard Recording System during an AF Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the clinical procedure impact of PURE-EP signals of interest vs. a standard recording system in a Redo AF population
The signals of interest will undergo a homogenization process to remove all identifiers of the system used. At a later time, a blinded electrophysiologist reviewer will evaluate the signals for clinical relevance and procedural impact from both systems using the same Blinded Signal Assessment Form. The Blinded Assessment Form results will be compared to both each other and what was done at the procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start3 Mar 2021
- 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.
- Other trials for Atrial Fibrillation RecurrentStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 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
- NCT04964440
- Sponsor's protocol ID
- Redo AF Sub Study of Pure EP 2
- Status last verified
- Feb 2022
- First submitted
- 2 Jul 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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
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
- Redo AF Sub Study (of the Pure EP 2.0 Main Study)
- ClinicalTrials.gov ID
- NCT04964440
- Acronym / sponsor ID
- Redo AF Sub Study of Pure EP 2
- Conditions
- Atrial Fibrillation Recurrent
- Keywords
- reoccurring, repeat, revision, redo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BioSig Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 29 Jan 2022 (actual)
- First posted
- 16 Jul 2021 (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 a sub study of the Pure EP 2.0 trial. In a redo atrial fibrillation population, this study is designed to collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of interest during a redo ablation procedure. These signals are later evaluated for clinical relevance and impact on the procedure.
Detailed description
Cardiac electrophysiologists rely on the display of electrograms when performing 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.
In a redo Atrial Fibrillation (AF) procedure, the patient had previously undergone an AF ablation procedure, but is still having AF episodes, which can be life threatening and have been shown to lead to strokes. Since the original AF procedure involved burning or freezing of myocardial tissue, this is now additional scar tissue and may cause more complex electrograms and intracardiac signals.
In this sub study, both the PURE EP™ system and the GE Cardiolab system will be running and recording signals during the entire procedure, with one of the systems displayed on the screen in the procedure room to guide the physician's decision-making. Even numbered subjects will be PURE EP™ guided and odd numbered subjected will be GE CardioLab guided. All other aspects of the procedure will proceed per standard of care. The study will be collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of interest during a redo ablation procedure.
After the physician has completed ablation treatment, matching signals of interest will be extracted from both the PURE EP™ system and the GE Cardiolab recording system as described in the main study. At a later date, a blinded electrophysiologist reviewer will evaluate the signals from both systems with a focus on tissue viability signals and the impact on the procedure. The survey results will then be compared to see the differences in clinical procedure decision-making based on the signal samples.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PURE EP Guided Procedures | – | Device: Pure-EPRedo AF procedures guided by Pure EP System during an AF Ablation |
| Standard Recording System Guided Procedures | – | –Redo AF procedures guided by the Standard Recording System during an AF Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Atrial Fibrillation
Key inclusion criteria (3 listed)
- Patients undergoing scheduled elective cardiac ablation procedures who have signed an informed consent
- Patients who are > 18 years of age.
- Patients undergoing a repeat elective cardiac AF Procedure
Key exclusion criteria (9 listed)
- A complex arrhythmia secondary to a reversible cause
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- Any cardiac surgery within the past 60 days (2 months) (includes PCI)
- Concurrent enrollment in a study evaluating another device or drug
- A complex arrhythmia secondary to electrolyte imbalance, thyroid disease or non-cardiac issue
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-EPAdvanced Signal Acquisition and Processing | Device | PURE EP Guided Procedures |
Primary outcome
To assess the clinical procedure impact of PURE-EP signals of interest vs. a standard recording system in a Redo AF population
Time frame: 6 months
The signals of interest will undergo a homogenization process to remove all identifiers of the system used. At a later time, a blinded electrophysiologist reviewer will evaluate the signals for clinical relevance and procedural impact from both systems using the same Blinded Signal Assessment Form. The Blinded Assessment Form results will be compared to both each other and what was done at the procedure.
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.
- Individual participant dataSharing planned: Yes. 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation Recurrent, run by BioSig Technologies, Inc. at 1 site 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 3 inclusion and 9 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 1 site 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?
To assess the clinical procedure impact of PURE-EP signals of interest vs. a standard recording system in a Redo AF population (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.