AI Powered Mapping Technology for Identifying Arrhythmias
NCT ID: NCT06939478
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
110 participants
OBSERVATIONAL
2025-08-27
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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Retrospective
Data will be collected from participants who have previously been treated with the approved device as part of routine care.
Arrhythmia Mapping
vMap is indicated for analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
Prospective
Data will be collected from participants prior to being treated with the approved device as part of routine care.
Arrhythmia Mapping
vMap is indicated for analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
Interventions
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Arrhythmia Mapping
vMap is indicated for analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
Eligibility Criteria
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Inclusion Criteria
2. The patient can provide written informed consent, if applicable.
3. The patient is greater than or equal to 18 years old
Prospective Arm:
1. Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
2. The patient can provide written informed consent, if applicable.
3. The patient is greater than or equal to 18 years old
Exclusion Criteria
1. Non-inducible arrhythmia (unless pre-mapped via vMap prior to the procedure).
2. Patients in whom no ablation was performed using the vMap equipment.
3. Inability to obtain 12-lead ECG of sufficient quality for vMap analysis.
4. In the opinion of the Investigator, the participant is not suitable and has a contraindication to undergo the ablation procedure.
18 Years
ALL
No
Sponsors
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Vektor Medical
INDUSTRY
Heart Rhythm Clinical and Research Solutions, LLC
OTHER
Responsible Party
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Locations
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Grandview Medical Center
Birmingham, Alabama, United States
Ascension St. Vincent's
Jacksonville, Florida, United States
HCA Florida Healthcare
Miami, Florida, United States
OhioHealth
Columbus, Ohio, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Susan Thorington
Role: primary
Carol Chalkley
Role: primary
Isabel Vital
Role: primary
Christina Belcher
Role: primary
Katie Shoemaker
Role: primary
Other Identifiers
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VITAL-EP
Identifier Type: -
Identifier Source: org_study_id