跳至主要内容
临床试验/NCT07621055
NCT07621055招募中不适用

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

Volta Medical3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Volta Medical
入组人数
150
试验地点
3

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
Volta Medical
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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