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

Launched by VOLTA MEDICAL · Oct 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of an artificial intelligence (AI) software called Volta Medical during a procedure known as ablation, which helps treat a heart condition called atrial fibrillation (AF). The goal is to see how safe and effective this AI software is in real-life situations, meaning it's used in everyday medical practice rather than in a controlled lab environment. The study will also collect information on the costs and benefits of using this tailored approach to treatment.

To participate in this trial, you must be at least 18 years old and a candidate for catheter ablation for atrial fibrillation or related heart issues. You should be able to give informed consent and, if you're in France, be part of the French social security system. Throughout the study, participants can expect to receive standard care while the effectiveness of the AI software is monitored. It's important to know that some people may not be eligible, such as those who are pregnant or unable to participate for personal reasons.

Gender

ALL

Eligibility criteria

• 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 VX1 or Volta AF-Xplorer or 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.
• • 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 an investigational study evaluating another device, biologic, or drug.