AI Powered Mapping Technology for Identifying Arrhythmias

NCT06939478 | Recruiting

• 1 other identifier: VITAL-EP
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (2)

• AF Ablation rate of procedural efficacy

  AF termination or AF non-inducibility in AF ablation cases

  Day of procedure

• Focal Arrhythmia Ablation rate of procedural efficiency

  Total procedure time, fluoroscopy time

  Day of procedure

Study Arms (2)

Retrospective

Data will be collected from participants who have previously been treated with the approved device as part of routine care.

Device: Arrhythmia Mapping

Prospective

Data will be collected from participants prior to being treated with the approved device as part of routine care.

Device: Arrhythmia Mapping

Interventions

Arrhythmia Mapping DEVICE

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

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will be derived from subjects scheduled for cardiac ablation who meet inclusion and exclusion criteria for the registry.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Rhythm Clinical and Research Solutions, LLC: lead
• Vektor Medical: collaborator

Study Sites (5)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

NOT YET RECRUITING

Ascension St. Vincent's

Jacksonville, Florida, 43304, United States

RECRUITING

HCA Florida Healthcare

Miami, Florida, 33133, United States

NOT YET RECRUITING

OhioHealth

Columbus, Ohio, 43214, United States

NOT YET RECRUITING

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ellen Mae Torres

CONTACT

408-857-2969; etorres@hrcrs.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: August 27, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (5)