RecruitingNCT06939478
AI Powered Mapping Technology for Identifying Arrhythmias
vMap Informed Targeting of Arrythmia Location EP
Sponsor
Heart Rhythm Clinical and Research Solutions, LLC
Enrollment
110 participants
Start Date
Aug 27, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
Exploratory, hypothesis-generating study evaluating the impact of vMap on procedural efficiency, acute success, and work flow optimization.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- Retrospective 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
- 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
Exclusion Criteria5
- 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.
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Interventions
DEVICEArrhythmia Mapping
vMap is indicated for analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06939478
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