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)

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

View Full Details on ClinicalTrials.gov

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NCT06939478


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