Volta AI software in real-world AF ablation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This PMCF study observes acute and long-term safety and performance of Volta AF-Xplorer II during AF ablation in routine clinical practice. It uses next-generation mapping and ablation tools, with the ablation approach chosen by the operator. Participants are followed through standard care visits at 3, 6, 9 and 24 months, collecting adverse events, arrhythmia recurrences, heart failure symptoms, AF-related symptoms, and a general health quality-of-life measure. The study records outcomes from enrollment to 24 months post-ablation, without imposing new workflows.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient aged 18 years or older.
2. 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.
3. Patient able and willing to provide written informed consent to participate in the study.
4. Only for France: Patient affiliated to the French social security system.

Exclusion Criteria:

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

Where it's running

• Hôpital Saint-Joseph Marseille
  Marseille, France Recruiting
• Centre Cardiologique du Nord
  Saint-Denis, France Not yet recruiting
• Clinique Rhéna
  Strasbourg, France Not yet recruiting

Study contacts

• Principal investigator: Clément BARS, MD — Hôpital Saint Joseph Marseille
• Study coordinator: Paola MILPIED
• Email: paola.milpied@volta-medical.com
• Phone: +33768025499

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.