vMap® Clinical Studies

The vMap Study

Forward-Solution Noninvasive Computational Arrhythmia Analysis

Blinded, multi-center, and independently adjudicated study with 225 patients

Atrial and ventricular arrhythmias were studied, as well as pacing

Hypothesis: vMap can help identify the locations of arrhythmias and pacing ​


vMap compared to ’gold standard’ site of successful ablation or pacing during EP study and ablation​​​

Conclusions: Computational ECG mapping using a forward-solution approach exceeded pre-specified accuracy goals for arrhythmia and pacing localization. Spatial accuracy analysis demonstrated clinically actionable results. This rapid, noninvasive mapping technology may facilitate catheter-based and noninvasive targeted arrhythmia therapies.’

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The vMap Time Study

Impact of artificial intelligence arrhythmia mapping on timeto first ablation, procedure duration, and fluoroscopy use

A study to compare procedure metrics for the first vMap cases with pre-vMap cases

Cases matched by operator, institution, arrhythmia type and case complexity​

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Key findings

22.6%
reduction in procedure duration​
43.7%
reduction in fluoroscopy time​
18%
Increase in procedure volume​

Impact for AF

Success rates of ECG mapping for PVI + Atrial Fibrillation Drivers

Summary

Recurrent AF is common, hypothesis that ECG mapping + PVI may identify AF drivers better than  PVI alone

27 study patients and 54 control patients (PVI only) with median 6-month follow-up

Patients had persistent AF, recurrent AF after prior ablation, or AF associated with atrial flutter or focal atrial tachycardia.

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Key finding

86.5%​ vs​ 48.0%
Freedom from AF and AT on or off antiarrhythmic medications versus 48.0% for controls (P = 0.006)3

Impact for VT

Outcome improvements associated with vMap in Unstable VT

Multi-center study of consecutive patients undergoing ablation for unstable VT against historical control adjusted for age, EF % and ischemic cardiomyopathy

Out of 32 consecutive patients undergoing ECG mapping guided VT ablation, 26 had unstable VT

6-month follow-up

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Key findings

ECG-guided ablation of unstable VT was associated with significantly decreased VT recurrence or death
(p=0.01, HR=0.23 [CI 0.07-0.70]4
99%
Reduction in burden of ICD shocks at 6 months4

The results were not impacted by lead placement or patient anatomy2

Radio-Ablation Planning Study Utilizing vMap

Computational ECG mapping and respiratory gating to optimize stereotactic ablative radiotherapy workflow for refractory ventricular tachycardia.

This peer-reviewed article concluded that vMap and protocol-based respiratory gating may help facilitate radioablation planning and maintain efficacy during therapy.

The prospective, dual-site study reported that a new non-invasive workflow using vMap may help facilitate the radioablation planning workflow. The study concluded that radio-ablation using vMap’s 12-lead ECG mapping and respiratory gated delivery may provide short-term safety and maintain efficacy during therapy in patients with advanced structural heart disease and refractory ventricular tachycardia.*

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Key findings

86.5%​ vs​ 48.0%
Freedom from AF and AT on or off antiarrhythmic medications versus 48.0% for controls (P = 0.006)3
REFERENCES: ​*Data on file​