AI Powered Mapping Technology for Identifying Arrhythmias

Recruiting

• Conditions: Arrhythmias, Cardiac

• Registration Number: NCT06939478
• Lead Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

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. 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 Timeline

• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-15
• Study First Posted: 2025-04-22
• Study Start: 2025-08-27
• Status Verified: 2025-10
• Primary Completion: 2025-10
• Last Update Submitted: 2025-10-29
• Last Update Posted: 2025-10-30
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AF Ablation rate of procedural efficacy	Day of procedure	AF termination or AF non-inducibility in AF ablation cases
Focal Arrhythmia Ablation rate of procedural efficiency	Day of procedure	Total procedure time, fluoroscopy time

Trial Locations

Locations (5)

Grandview Medical Center; 🇺🇸 Birmingham, Alabama, United States

Ascension St. Vincent's; 🇺🇸 Jacksonville, Florida, United States

HCA Florida Healthcare; 🇺🇸 Miami, Florida, United States

OhioHealth; 🇺🇸 Columbus, Ohio, United States

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States