RecruitingNot Applicable

VOLta Medical AI-software in REal-World During AF Ablation

France150 participantsStarted 2026-06-16

Plain-language summary

This PMCF study "VOLTAIRE-AF" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping and ablation technologies over a 24-month follow-up and in "real life"clinical practice, without any imposed clinical workflow.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient aged 18 years or older.
. Patient candidate for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using Volta AF-Xplorer II.
. Patient able and willing to provide written informed consent to participate in the study.
. Only for France: Patient affiliated to the French social security system.

Exclusion criteria

. Contraindication to AF/AT catheter ablation using RF and/or PFA.
. Patient who is or could potentially be pregnant.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Freedom from clinically significant AF or atrial arrhythmia recurrence, after one or multiple ablation procedures, with or without antiarrhythmic drugs, at 12 and 24 months.

Timeframe: 24 months

Volta AF-Xplorer II-related Serious Incident rate

Timeframe: 24 months

Ablation procedure-related Serious Adverse Event rate

Timeframe: 24 months

Trial details

NCT IDNCT07621055

SponsorVolta Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-06

Contact for this trial

Paola MILPIED

+33768025499 paola.milpied@volta-medical.com

View on ClinicalTrials.gov More Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient aged 18 years or older.
. Patient candidate for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using Volta AF-Xplorer II.
. Patient able and willing to provide written informed consent to participate in the study.
. Only for France: Patient affiliated to the French social security system.

Exclusion criteria

. Contraindication to AF/AT catheter ablation using RF and/or PFA.
. Patient who is or could potentially be pregnant.

What they're measuring

Freedom from clinically significant AF or atrial arrhythmia recurrence, after one or multiple ablation procedures, with or without antiarrhythmic drugs, at 12 and 24 months.

Timeframe: 24 months

Volta AF-Xplorer II-related Serious Incident rate

Timeframe: 24 months

Ablation procedure-related Serious Adverse Event rate

Timeframe: 24 months