Volta Clinical Evidence Roadmap

The Volta Clinical Evidence Roadmap

One of the most ambitious clinical programs focused on the underserved complex Atrial Fibrillation (AF) patient

Our Approach

Industry-Leading Research Scope and quality

Published

2017

AF Ablation Guided by Spatiotemporal Electrogram Dispersion Whithout Pulmonary Vein Isolation

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2022

Ev-AIFib
Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation

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2025

The Tailored-AF Trial
Multicenter RCT

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2026

RESTART Trial
Multicenter Prospective Study for Redo Procedures

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Ongoing

Clinical Registry
Multicenter Prospective Study

Complex Substrate Patients Represent AF’s Most Underserved Communities

Complex substrate patients represent the most difficult cases across the atrial fibrillation spectrum. Advanced disease, comorbidities, and prior interventions drive extensive structural and electrical remodeling of the heart, leaving many patients with persistent symptoms and limited treatment options.

When conventional approaches fall short, the burden grows for patients, clinicians, and healthcare systems. These patients need innovative solutions that recognize and address their clinical complexity.

Redefining Treatment for Complex AF

Extensive clinical data underscores Volta’s unique capability to address these complex substrate patient populations.

Persistent AF ≥ 6 months

Patients with more progressed AF often present as more complex substrate

AF duration ≥6 months is associated with progressive atrial remodeling.
Arrhythmogenic drivers extend beyond the pulmonary veins.
Substrate progression often becomes biatrial, with right atrial involvement in longer-standing disease.
Standard success rates decline significantly as AF duration increases.

TAILORED-AF PUBLICATION

The benefit of a Tailored approach is more pronounced in patients with longer AF duration and avanced atrial remodeling; in whom PVI alone has only poor to moderate success rates.

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Redo Patients with PV Isolated

How do we treat them?

Redo patients with recurrent AF despite durable PVI remain a clinical challenge.

Redo patients often experience multiple hospitalizations, cardioversions and reduced quality of life.
There is no consensus strategy for treating this population.
Prior trials on different strategies reported arrhythmia-free rates of only 30-50%.

THE RESTART TRIAL

AI-guided dispersion ablation demonstrated high freedom from arrhythmia, improved quality of life, and a favorable safety profile in this challenging population.

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WOMEN WITH AF

Addressing AF Complexity in Women

Women with AF typically :

Present with more symptoms and comorbidities.
Have a more extensive atrial substrate.
Are less likely to undergo AF ablation and have higher post-ablation AF recurrence levels.
Standardized extra-PV ablation strategies have not shown clear benefit over PVI alone in women.

TAILORED-AF SUB-ANALYSIS

AI-guided tailored ablation significantly increases 12-month arrhythmia-free survival after just one procedure in women with persistent AF.
The findings also suggest a potential reduction in sex‑based disparities in outcomes.

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HEART FAILURE PATIENTS

Heart Failure and AF: A Complex Interaction

AF and heart failure (HF) frequently coexist, creating a complex clinical scenario that accelerates disease progression and worsens outcomes.

AF increases mortality and morbidity in HF patients.
HF is a leading cause of hospitalization and readmission in older adults.
As HF progresses, atrial fibrosis and conduction heterogeneity increase, limiting the effectiveness of anatomical PVI alone.

TAILORED-AF SUB-ANALYSIS

Personalized, AI-guided ablation improves FFAF compared with PVI across all NYHA classes.
Patients with NYHA class III symptoms experienced the greatest benefit, with higher FFAF/AT after one or two procedures.

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Legal Mentions and References

¹Distribution and Risk Profile of Paroxysmal, Persistent, and Permanent Atrial Fibrillation in Routine Clinical Practice” Chern-En Chiang, Lisa Naditch-Brûlé, Jan Murin, Marnix Goethals, Hiroshi Inoue, James O’Neill, et al.
²Kirchhof et al.. "Catheter ablation in patients with persistent atrial fibrillation." European Heart Journal 38.1 (2017): 20-26.

ABOUT
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The Volta AF-Xplorer™II system is a class IIa Medical Device manufactured by Volta Medical. This product is CE marked by TÜV Rheinland LGA Products GmbH (0197) and FDA cleared.

INDICATIONS, SAFETY & WARNINGS

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See Instructions for Use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. All safety considerations, cautions and warnings that apply to the general use of a medical system in an operating room, also apply while using Volta AF-Xplorer™ II application. There are no known potential adverse events associated with the use of Volta AF-Xplorer™ II.

Indications: The Volta AF-Xplorer™ II assists operators in the real-time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia.

Contraindications: The Volta AF-Xplorer™ II has no specific contraindications.
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All pictures shown are for illustration purpose only.
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^‡ Indicates a third party trademark, which is property of its respective owner.