AI Powered Mapping Technology for Identifying Arrhythmias (VITAL-EP)

vMap Informed Targeting of Arrythmia Location EP

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

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: Arrhythmia Mapping

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. 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.

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
  • Florida
    • Jacksonville, Florida, United States, 43304
      • Ascension St. Vincent's
    • Miami, Florida, United States, 33133
      • HCA Florida Healthcare
  • Ohio
    • Columbus, Ohio, United States, 43214
      • OhioHealth
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Retrospective Arm:

Inclusion Criteria:

1. Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
2. The patient can provide written informed consent, if applicable.
3. The patient is greater than or equal to 18 years old

Prospective Arm:

Inclusion Criteria:

1. Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
2. The patient can provide written informed consent, if applicable.
3. 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:

1. Non-inducible arrhythmia (unless pre-mapped via vMap prior to the procedure).
2. Patients in whom no ablation was performed using the vMap equipment.
3. Inability to obtain 12-lead ECG of sufficient quality for vMap analysis.
4. In the opinion of the Investigator, the participant is not suitable and has a contraindication to undergo the ablation procedure.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective; Data will be collected from participants who have previously been treated with the approved device as part of routine care.	Device: Arrhythmia Mapping; vMap is indicated for analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
Prospective; Data will be collected from participants prior to being treated with the approved device as part of routine care.	Device: Arrhythmia Mapping; vMap is indicated for analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
• Collaborators: Vektor Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2025
• Primary Completion (Actual): March 5, 2026
• Study Completion (Actual): May 15, 2026

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac
• Other Study ID Numbers: VITAL-EP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No