AI Powered Mapping Technology for Identifying Arrhythmias

Not yet 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

• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Study Start: 2025-07
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

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

Inclusion Criteria

• A cardiac ablation (de novo or repeat) procedure will occur guided by vMap.
• A confirmed cardiac arrythmia has been identified on a 12-lead ECG.
• The patient is greater than or equal to 18 years old.
• The patient can provide written informed consent.

Exclusion Criteria

• Non-inducible arrhythmia (unless pre-mapped via vMap prior to the procedure).
• Patients in whom no ablation was performed.
• Inability to obtain 12-lead ECG of sufficient quality for vMap analysis.

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