Arrhythmias, CardiacVITAL-EPNCT06939478
AI Powered Mapping Technology for Identifying Arrhythmias
An observational study of Arrhythmias, Cardiac, run by Heart Rhythm Clinical and Research Solutions, LLC at 5 sites in United States.
Trial summary
Exploratory, hypothesis-generating study evaluating the impact of vMap on procedural efficiency, acute success, and work flow optimization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- Arrhythmia Mapping
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Aug 2025to 15 May 2026
- How long will I take part?
- 30 Days
- 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: Study population will be derived from subjects scheduled for cardiac ablation who meet inclusion and exclusion criteria for the registry.
Who may be able to join
- Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
- The patient can provide written informed consent, if applicable.
- The patient is greater than or equal to 18 years old
- Prospective Arm:
- Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
- The patient can provide written informed consent, if applicable.
- The patient is greater than or equal to 18 years old
Who cannot join
- Participants who meet any one of the following criteria will be a screen failure and excluded from participation:
- Non-inducible arrhythmia (unless pre-mapped via vMap prior to the procedure).
- Patients in whom no ablation was performed using the vMap equipment.
- Inability to obtain 12-lead ECG of sufficient quality for vMap analysis.
- In the opinion of the Investigator, the participant is not suitable and has a contraindication to undergo the ablation procedure.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Grandview Medical Center
Birmingham, Alabama, 35243
OhioHealth
Columbus, Ohio, 43214
Ascension St. Vincent's
Jacksonville, Florida, 43304
HCA Florida Healthcare
Miami, Florida, 33133
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: vMap Informed Targeting of Arrythmia Location EP
Exploratory, hypothesis-generating study evaluating the impact of vMap on procedural efficiency, acute success, and work flow optimization.
Read the detailed description
The registry is a retrospective and prospective, post-approval, multicenter, single-arm, all-comers registry with two cohorts:
Retrospective Cohort: approximately 60 patients across two sites. Prospective Cohort: approximately 50 patients across two sites. This registry aims to collect real-world data on the clinical utility, safety, and procedural efficiency of vMap-guided ablation procedures.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- Arrhythmia Mapping
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arrhythmia MappingDevice
vMap is indicated for analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Data will be collected from participants who have previously been treated with the approved device as part of routine care. Receives: Device: Arrhythmia Mapping | |
| Prospective | Data will be collected from participants prior to being treated with the approved device as part of routine care. Receives: Device: Arrhythmia Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF Ablation rate of procedural efficacy
AF termination or AF non-inducibility in AF ablation cases
Measured: Day of procedure
Focal Arrhythmia Ablation rate of procedural efficiency
Total procedure time, fluoroscopy time
Measured: Day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start27 Aug 2025
- Primary completion5 Mar 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies 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
- Other
- Enrolment
- 112 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Vektor Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939478
- Sponsor's protocol ID
- VITAL-EP
- Acronym
- VITAL-EP
- Status last verified
- May 2026
- First submitted
- 15 Apr 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- vMap Informed Targeting of Arrythmia Location EP
- ClinicalTrials.gov ID
- NCT06939478
- Acronym / sponsor ID
- VITAL-EP / VITAL-EP
- Conditions
- Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLCUniversity, hospital or other
- Collaborators
- Vektor Medical
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 22 Apr 2025 (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.
Exploratory, hypothesis-generating study evaluating the impact of vMap on procedural efficiency, acute success, and work flow optimization.
Detailed description
The registry is a retrospective and prospective, post-approval, multicenter, single-arm, all-comers registry with two cohorts:
Retrospective Cohort: approximately 60 patients across two sites. Prospective Cohort: approximately 50 patients across two sites. This registry aims to collect real-world data on the clinical utility, safety, and procedural efficiency of vMap-guided ablation procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Device: Arrhythmia MappingData will be collected from participants who have previously been treated with the approved device as part of routine care. |
| Prospective | – | Device: Arrhythmia MappingData will be collected from participants prior to being treated with the approved device as part of routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be derived from subjects scheduled for cardiac ablation who meet inclusion and exclusion criteria for the registry.
Key inclusion criteria (7 listed)
- Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
- The patient can provide written informed consent, if applicable.
- The patient is greater than or equal to 18 years old
- Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
- The patient can provide written informed consent, if applicable.
Key exclusion criteria (5 listed)
- Participants who meet any one of the following criteria will be a screen failure and excluded from participation:
- Non-inducible arrhythmia (unless pre-mapped via vMap prior to the procedure).
- Patients in whom no ablation was performed using the vMap equipment.
- Inability to obtain 12-lead ECG of sufficient quality for vMap analysis.
- In the opinion of the Investigator, the participant is not suitable and has a contraindication to undergo the ablation procedure.
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 |
|---|---|---|
| Arrhythmia MappingvMap is indicated for analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician. | Device | Prospective, Retrospective |
Primary outcome
AF Ablation rate of procedural efficacy
Time frame: Day of procedure
AF termination or AF non-inducibility in AF ablation cases
Focal Arrhythmia Ablation rate of procedural efficiency
Time frame: Day of procedure
Total procedure time, fluoroscopy time
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 22 May 2026.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac, run by Heart Rhythm Clinical and Research Solutions, LLC at 5 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 7 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
AF Ablation rate of procedural efficacy (time frame: Day of procedure). The study lists 2 primary outcomes in all. 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 22 May 2026.