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)
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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