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NCT Number: NCT07621055

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint-Joseph Marseille, Marseille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

Cardiac mapping

Device

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.

Other names: Atrial fibrillation mapping, Ablation procedure

Primary outcomes

  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.

    Time frame: 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.

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

    Time frame: 24 months

  3. Ablation procedure-related Serious Adverse Event rate

    Time frame: 24 months

Secondary outcomes

  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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

  9. Health economics analysis including QALY metric

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Cecile BIELMANN

CONTACT

[email protected]

Paola MILPIED

CONTACT

[email protected]

+33768025499

Sponsors and collaborators

Lead sponsor

Volta Medical

Industry

Registry information

Official study title

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

Acronym: VOLTAIRE-AF

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 2, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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