Active — Not RecruitingNot Applicable

Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation

France186 participantsStarted 2023-10-27

Plain-language summary

The goal of this Observational Prospective Multi-center Study is to observe the acute and long-term safety and performance outcomes after spatiotemporal dispersion-based AF/AT ablation utilizing the Volta Medical AI software in "real-life" clinical practice, without any imposed clinical workflow. Moreover, this study will allow to collect medico-economic data related to the tailored ablation strategy guided by the Volta Medical AI software.

Who can participate

Age range18 Years

SexALL

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 VX1 or Volta AF-Xplorer or 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.
✕. 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\&#39;s refusal to participate in the study.
✕. Enrollment in an investigational study evaluating another device, biologic, or drug.

What they're measuring

Freedom from clinically significant AF or atrial arrhythmia recurrence, after one or multiple ablation procedures, with or without antiarrhythmic drugs, stratified by type of clinical workflow.

Timeframe: [24 months]

VX1/Volta AF-Xplorer/Volta AF-Xplorer II-related Incident rate during ablation procedure.

Timeframe: [24months]

VX1/Volta AF-Xplorer/Volta AF-Xplorer II-related Adverse Event rate.

Timeframe: [24months]

Trial details

NCT IDNCT06083012

SponsorVolta Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-04-27

View on ClinicalTrials.gov More Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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 VX1 or Volta AF-Xplorer or 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.
✕. 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\&#39;s refusal to participate in the study.
✕. Enrollment in an investigational study evaluating another device, biologic, or drug.

What they're measuring

Freedom from clinically significant AF or atrial arrhythmia recurrence, after one or multiple ablation procedures, with or without antiarrhythmic drugs, stratified by type of clinical workflow.

Timeframe: [24 months]

VX1/Volta AF-Xplorer/Volta AF-Xplorer II-related Incident rate during ablation procedure.

Timeframe: [24months]

VX1/Volta AF-Xplorer/Volta AF-Xplorer II-related Adverse Event rate.

Timeframe: [24months]