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Status:

RECRUITING

AI Powered Mapping Technology for Identifying Arrhythmias

Lead Sponsor:

Heart Rhythm Clinical and Research Solutions, LLC

Collaborating Sponsors:

Vektor Medical

Conditions:

Arrhythmias, Cardiac

Eligibility:

All Genders

18+ years

Brief Summary

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. Prospe...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 27 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT06939478

Start Date

August 27 2025

End Date

December 1 2025

Last Update

November 10 2025

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Grandview Medical Center

Birmingham, Alabama, United States, 35243

2

Ascension St. Vincent's

Jacksonville, Florida, United States, 43304

3

HCA Florida Healthcare

Miami, Florida, United States, 33133

4

OhioHealth

Columbus, Ohio, United States, 43214