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OpenTrials
Completed

NCT Number: NCT06939478

AI Powered Mapping Technology for Identifying Arrhythmias

Exploratory, hypothesis-generating study evaluating the impact of vMap on procedural efficiency, acute success, and work flow optimization.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grandview Medical Center, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Retrospective Arm:

Inclusion criteria

  • 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:

Inclusion criteria

  • 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 criteria

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.

Treatment and study plan

Arrhythmia Mapping

Device

vMap is indicated for analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.

Primary outcomes

  1. AF Ablation rate of procedural efficacy

    Time frame: Day of procedure

    AF termination or AF non-inducibility in AF ablation cases

  2. Focal Arrhythmia Ablation rate of procedural efficiency

    Time frame: Day of procedure

    Total procedure time, fluoroscopy time

Sponsors and collaborators

Lead sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Other

Collaborators

  • Vektor Medical

Registry information

Official study title

vMap Informed Targeting of Arrythmia Location EP

Acronym: VITAL-EP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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