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Atrial FibrillationVOLTAIRE-AFNCT07621055

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

An observational study of Atrial Fibrillation and Atrial Arrhythmia, run by Volta Medical at 3 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cardiac mapping
Type of treatment
Medical device
How many people
150 participants
Where
3 sitesFrance
Study dates
16 Jun 2026to Jun 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All adult patient candidate eligible 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.

Who may be able to join

  • 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.

Who cannot join

  • Contraindication to AF/AT catheter ablation using RF and/or PFA.
  • Patient who is or could potentially be pregnant.
  • Person deprived of liberty or under guardianship.
  • Person unable to undergo a medical monitoring for geographical, social or psychological reasons.
  • Patient's refusal to participate in the study.
  • Enrollment in a premarket clinical study evaluating device, drug or biologic product.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Paola MILPIED contact

+33768025499

paola.milpied@volta-medical.com

Cecile BIELMANN contact

cecile.bielmann@volta-medical.com

France3 sites, 3 recruiting

  • Hôpital Saint-Joseph Marseille

    Marseille, 13008

    Clément Bars, MD

    Recruiting

  • Centre Cardiologique du Nord

    Saint-Denis, 93207

    Antoine Lepillier, MD

    Not yet recruiting

  • Clinique Rhéna

    Strasbourg, 67000

    Babé Bakouboula, MD

    Not yet recruiting

Other trials in France

About this study

Official title: Real-World Experience of Volta Medical AI-software During AF Ablation Using Next-generation Mapping and Ablation Technologies

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.

Read the detailed description

All patients enrolled are treated for atrial fibrillation/tachycardia via a catheter ablation procedure using the last generation of Volta Medical AI software (Volta AF-Xplorer II) during the mapping phase to identify areas of interest specific to the patient. The ablation approach is free and chosen by the operator according to standard practice. Intraoperative and postoperative follow-up will be performed as in routine clinical practice during AF ablation procedures: hospitalization for ablation procedure and standard postoperative quarterly visits (at 3 months, at 6 months and/or 9 months as per the study investigator's Standard Of Care) then annual visits up to 24 months post-ablation. Adverse Events, recurrences of atrial arrhythmia, Heart Failure related symptom score ("NYHA") and AF related symptoms (EHRA score) are collected from the patient's enrollment until the patient's study termination. A quality-of-life questionnaire related to general health (EQ-5D-3L) is collected during the preoperative visit and at least during annual follow-up visits. The patient's study-termination corresponds to the last annual visit at 24 months post-ablation index.

Being tested
Cardiac mapping
Keywords
Volta AF-Xplorer II, Artificial Intelligence, Cardiac ablation, Medical Device, Software, Volta Medical, Atrial Arrhythmia
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac mappingDevice

    Also called Atrial fibrillation mapping, Ablation procedure

    All patients enrolled are treated for their atrial fibrillation/tachycardia via a catheter ablation procedure using the last generation of Volta Medical AI software (Volta AF-Xplorer II, used in accordance with its approved indication as per of its IFU) during the mapping phase to identify areas of interest specific to the patient.

    The ablation approach is free and chosen by the operator according to his standard practice. The two main phases of the ablation procedure are:

    • 3D mapping of the atria and location of areas of interest;
    • Catheter ablation at the operator's discretion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    An Atrial Arrhythmia episode (AF/AFL/AT ≥ 30s) will be determined to be clinically significant if it results in an unexpected treatment change (e.g. new anti-arrhythmic drug or higher dose of AAD, repeat ablation procedure, DC cardioversion), or if it is accompanied by worsening of symptoms related to AF, considering a standard 3-month blanking period.

    Measured: 24 months

  2. Volta AF-Xplorer II-related Serious Incident rate

    Measured: 24 months

  3. Ablation procedure-related Serious Adverse Event rate

    Measured: 24 months

Secondary outcomes (9)

  1. Progression of Quality-Of-Life score ("EQ-5D-3L") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months).

    Measured: 24 months

  2. Progression of the AF related symptom score ("EHRA") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months).

    Measured: 24 months

  3. Progression of the Heart Failure related symptom score ("NYHA") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months).

    Measured: 24 months

  4. Hospitalization rate during the post-ablation follow-up period.

    Measured: 24 months

  5. Serious Adverse Event rate during the post-ablation follow-up period.

    Measured: 24 months

  6. Average number of ablation procedures per patient up to 24 months follow-up.

    Measured: 24 months

  7. Average number of cardioversions per patient up to 24 months follow-up

    Measured: 24 months

  8. Progression of patient proportion under antiarrhythmic drugs and/or anticoagulant treatments during the study.

    Measured: 24 months

  9. Health economics analysis including QALY metric

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start16 Jun 2026
  3. Primary completionJun 2030 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07621055
Sponsor's protocol ID
CLIPL-05-002
Acronym
VOLTAIRE-AF
Status last verified
Jun 2026
First submitted
27 May 2026
Last updated
22 Jun 2026
Results posted
No
Individual data sharing
No

Publications

  • Deisenhofer I, Albenque JP, Busch S, Gitenay E, Mountantonakis SE, Roux A, Horvilleur J, Bakouboula B, Oza S, Abbey S, Theodore G, Lepillier A, Guyomar Y, Bessiere F, Jan Smit J, Mohr Durdez T, Milpied P, Appetiti A, Guerrero D, De Potter T, De Chillou C, Goldbarg S, Verma A, Hummel JD; TAILORED-AF Investigators. Artificial intelligence for individualized treatment of persistent atrial fibrillation: a randomized controlled trial. Nat Med. 2025 Apr;31(4):1286-1293. doi: 10.1038/s41591-025-03517-w. Epub 2025 Feb 14.

    PubMed 39953289

  • Hummel JD, Zei PC, Metzl M, Deisenhofer I, Rashid H, Morales G, Horvilleur J, Mountantonakis S, Albenque JP, Vasaiwala S, De Potter T, Lador A, Magnano A, Chicos AB, Silverstein J, Guerrero D, Beguin S, El-Benna A, Nguyen-Tu MS, Lotteau S, Milpied P, Durdez TM, Kalifa J, Bars C, Seitz J, D'Souza B, Cooper DH, Nair D, Lakkireddy D. Reablation of atrial fibrillation targeting electrogram dispersion in patients with isolated veins: The RESTART trial. Heart Rhythm. 2026 May;23(5):1083-1090. doi: 10.1016/j.hrthm.2026.01.042. Epub 2026 Feb 2.

    PubMed 41638617

  • Deisenhofer I, Seitz J, Nguyen-Tu MS, Lotteau S, Bars C, Albenque JP, Busch S, Gitenay E, Mountantonakis S, Roux A, Horvilleur J, Bakouboula B, Oza S, Abbey S, Theodore G, Lepillier A, Guyomar Y, Bessiere F, Smit JJ, Rajendra A, Cooper DH, Rashid H, De Potter T, De Chillou C, Goldbarg S, Verma A, Morales G, Milpied P, Hummel JD, Kalifa J. Women with persistent atrial fibrillation need more than pulmonary vein isolation: personalised extra-pulmonary vein ablation strategy vs. pulmonary vein isolation alone in the TAILORED-AF trial. Europace. 2025 Oct 31;27(11):euaf281. doi: 10.1093/europace/euaf281.

    PubMed 41311304

  • Deisenhofer I, Seitz J, Lotteau S, Albenque JP, Busch S, Nguyen-Tu MS, Dayot A, Dalmau M, Leukovich H, Bars C, De Potter T, de Chillou C, Goldbarg S, Appetiti A, Milpied P, Durdez TM, Hummel JD, Kalifa J. Targetable atrial tachycardias after artificial intelligence-guided ablation of persistent atrial fibrillation. Heart Rhythm. 2026 Mar;23(3):e357-e367. doi: 10.1016/j.hrthm.2025.11.018. Epub 2025 Nov 14.

    PubMed 41242590

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Atrial Arrhythmia, run by Volta Medical at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paola MILPIED (+33768025499, paola.milpied@volta-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07621055, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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