Health TrialsbyHealthPanel

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

ConditionsAtrial FibrillationAtrial ArrhythmiaArrhythmias, Cardiac
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVolta Medical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

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.

Time frame
24 months
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Volta Medical

Lead sponsor

Source ClinicalTrials.gov
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