AI-powered heart mapping to find arrhythmias

vMap Informed Targeting of Arrythmia Location EP

This registry will test whether vMap, an AI-powered mapping tool, helps doctors find and treat heart rhythm problems more efficiently in adults having cardiac ablation.

Quick facts

• Study type: Observational
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Heart Rhythm Clinical and Research Solutions, LLC (Academic / other)
• Locations: 5 sites (Birmingham, Alabama and 4 other locations)
• Trial ID: NCT06939478 on ClinicalTrials.gov

What this trial studies

This is a post-approval, multicenter, single-arm registry combining retrospective (about 60 patients) and prospective (about 50 patients) cohorts to collect real-world data on vMap-guided ablations. Participating centers will include several U.S. hospitals where the vMap equipment was used during standard-of-care ablation procedures. The registry captures procedural efficiency, acute procedural success, workflow impacts, and safety signals associated with using the vMap system. Data will be used for hypothesis generation and to inform future, more definitive studies.

Who should consider this trial

Good fit: Adults aged 18 or older undergoing standard-of-care cardiac ablation (de novo or repeat) in which the vMap equipment is used are the intended participants.

Not a fit: Patients with non-inducible arrhythmias (unless pre-mapped with vMap), those without ablation performed using vMap, inability to obtain adequate 12-lead ECGs for vMap analysis, or judged unsuitable by the investigator are unlikely to benefit from inclusion.

Why it matters

Potential benefit: If successful, vMap could shorten procedure times, improve acute arrhythmia identification and ablation success, and streamline clinical workflow for electrophysiology teams.

How similar studies have performed: Early reports of AI-assisted cardiac mapping have shown promising small-scale results, but large multicenter prospective registries remain limited and this approach is still relatively novel.

Eligibility criteria

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.

Where this trial is running

Birmingham, Alabama and 4 other locations

• Grandview Medical Center — Birmingham, Alabama, United States (Not_yet_recruiting)
• Ascension St. Vincent's — Jacksonville, Florida, United States (Recruiting)
• HCA Florida Healthcare — Miami, Florida, United States (Not_yet_recruiting)
• OhioHealth — Columbus, Ohio, United States (Not_yet_recruiting)
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Ellen Mae Torres

Conditions Arrhythmias, Cardiac