Cardiac ArrhythmiaNCT04559061
Vektor vMap™ Clinical Validation Study
An observational study of Cardiac Arrhythmia and Atrial Fibrillation, run by Vektor Medical at 4 sites in United States.
Trial summary
This is a retrospective, multi center clinical study collecting existing, de-identified subject data from medical records to be analyzed using an independent core laboratory to validate performance of a computational ECG mapping system (vMap™). Read more about this study
- Who is it for?
- Ages 22 to 100 years
- Conditions the study is for
- Cardiac Arrhythmia, Atrial Fibrillation, Ventricular Arrythmia
- What is being tested?
- Cardiac ablation procedure
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Dec 2020to 6 Apr 2021
- 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 22 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with cardiac arrhythmia that have undergone successful ablation procedures.
Who may be able to join
- Patient has one of the following clinical arrhythmia/pacing types:
- Atrial pacing
- Atrial fibrillation
- Ventricular pacing
- Premature ventricular complex
- Ventricular tachycardia
Show all 15Show fewer
- Ventricular fibrillation
- Focal atrial tachycardia
- Premature atrial complex
- Atrioventricular reentrant tachycardia
- Patient has undergone 'successful' routine, standard of care diagnostic electrophysiology (EP) study using intracardiac catheters as clinically indicated, guided by fluoroscopy and routine electroanatomic mapping, intracardiac echocardiography, and/or cardiac imaging such as CT or MRI.
- Patient has 12 lead electrogram data of clinical rhythms recorded on electrogram recording system.
- Patient has undergone a successful ablation procedure.
- Arrhythmia type and atrial/ventricular characteristics can be abstracted from patient medical records.
- Patient was between 22 and 100 years of age at time of EP study and ablation procedure.
Who cannot join
- Patients with unstable coronary artery disease, confirmed intracardiac thrombus, active sepsis, complex congenital heart disease, dextrocardia, severe pulmonary hypertension, decompensated heart failure, a mechanical heart valve, myocardial infarction within 1 month of ablation, inability to induce arrhythmia, unacceptable ECG data quality, and/or data included in the device training dataset.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, California, 29425
University of California San Diego Health
La Jolla, California, 92093
VA San Diego Healthcare System
San Diego, California, 92161
Sutter Health
San Francisco, California, 94107
About this study
Official title: Clinical Validation of the Vektor Computational ECG Mapping System (vMap™) for Atrial and Ventricular Arrhythmias/Pacing
This is a retrospective, multi center clinical study collecting existing, de-identified subject data from medical records to be analyzed using an independent core laboratory to validate performance of a computational ECG mapping system (vMap™).
- Conditions
- Cardiac Arrhythmia, Atrial Fibrillation, Ventricular Arrythmia, Premature Ventricular Complexes Multiple, Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- Cardiac ablation procedure
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Tachycardia, Ventricular, Ventricular Fibrillation, Atrial Premature Complexes, Tachycardia, Atrioventricular Nodal Reentry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac ablation procedureDevice
Retrospective data will be collected from cases where successful ablation was completed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of accuracy/agreement of vMap™ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT.
Measured: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.
Secondary outcomes (2)
Rate of accuracy/agreement of vMap™ in correctly identifying the chamber/region of the arrhythmia location for all arrhythmia types.
Measured: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.
Rate of accuracy/agreement of vMap™ in correctly identifying the segment of the arrhythmia treatment across all arrhythmia types.
Measured: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Dec 2020
- Primary completion6 Apr 2021
- Study completion6 Apr 2021
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vektor Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Experien Group
- Responsible party
- Sponsor
- Investigators
- Chris Villongco, PhD, Study chair, Vektor Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559061
- Sponsor's protocol ID
- 20-PR-1010
- Status last verified
- Apr 2021
- First submitted
- 10 Sep 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Krummen DE, Villongco CT, Ho G, Schricker AA, Field ME, Sung K, Kacena KA, Martinson MS, Hoffmayer KS, Hsu JC, Raissi F, Feld GK, McCulloch AD, Han FT. Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study. Circ Arrhythm Electrophysiol. 2022 Sep;15(9):e010857. doi: 10.1161/CIRCEP.122.010857. Epub 2022 Sep 7.
PubMed 36069189
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Vektor Computational ECG Mapping System (vMap™) for Atrial and Ventricular Arrhythmias/Pacing
- ClinicalTrials.gov ID
- NCT04559061
- Acronym / sponsor ID
- 20-PR-1010
- Conditions
- Cardiac Arrhythmia, Atrial Fibrillation, Ventricular Arrythmia, Premature Ventricular Complexes Multiple, Ventricular Tachycardia, Ventricular Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Vektor MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Experien Group
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 22 Sep 2020 (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 is a retrospective, multi center clinical study collecting existing, de-identified subject data from medical records to be analyzed using an independent core laboratory to validate performance of a computational ECG mapping system (vMap™).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 22 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with cardiac arrhythmia that have undergone successful ablation procedures.
Key inclusion criteria (15 listed)
- Patient has one of the following clinical arrhythmia/pacing types:
- Patient has undergone 'successful' routine, standard of care diagnostic electrophysiology (EP) study using intracardiac catheters as clinically indicated, guided by fluoroscopy and routine electroanatomic mapping, intracardiac echocardiography, and/or cardiac imaging such as CT or MRI.
- Patient has 12 lead electrogram data of clinical rhythms recorded on electrogram recording system.
- Patient has undergone a successful ablation procedure.
- Arrhythmia type and atrial/ventricular characteristics can be abstracted from patient medical records.
Key exclusion criteria (1 listed)
- Patients with unstable coronary artery disease, confirmed intracardiac thrombus, active sepsis, complex congenital heart disease, dextrocardia, severe pulmonary hypertension, decompensated heart failure, a mechanical heart valve, myocardial infarction within 1 month of ablation, inability to induce arrhythmia, unacceptable ECG data quality, and/or data included in the device training dataset.
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 |
|---|---|---|
| Cardiac ablation procedureRetrospective data will be collected from cases where successful ablation was completed. | Device | – |
Primary outcome
Rate of accuracy/agreement of vMap™ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT.
Time frame: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.
2 secondary outcomes
Rate of accuracy/agreement of vMap™ in correctly identifying the chamber/region of the arrhythmia location for all arrhythmia types.
Time frame: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.
Rate of accuracy/agreement of vMap™ in correctly identifying the segment of the arrhythmia treatment across all arrhythmia types.
Time frame: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.
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 8 Apr 2021.
- Derived from this study: PubMed 36069189Krummen DE, Villongco CT, Ho G, Schricker AA, Field ME, Sung K, Kacena KA, Martinson MS, Hoffmayer KS, Hsu JC, Raissi F, Feld GK, McCulloch AD, Han FT. Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study. Circ Arrhythm Electrophysiol. 2022 Sep;15(9):e010857. doi: 10.1161/CIRCEP.122.010857. Epub 2022 Sep 7.
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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.
Chris Villongco, PhD study chair
Vektor Medical
4 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 and Atrial Fibrillation, run by Vektor Medical at 4 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 15 inclusion and 1 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Rate of accuracy/agreement of vMap™ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT. (time frame: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.). 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 NCT04559061, 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 8 Apr 2021.