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

Recruiting

• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Arrhythmia

• Registration Number: NCT06083012
• Lead Sponsor: Volta Medical

Brief 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.

Detailed Description

All patients enrolled are treated for atrial fibrillation/tachycardia via a catheter ablation procedure using Volta Medical AI software 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 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.

Study Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-13
• Study Start: 2023-10-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Primary Completion: 2027-04-27
• Study Completion: 2027-04-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	[24 months]
VX1/Volta AF-Xplorer/Volta AF-Xplorer II-related Incident rate during ablation procedure.	[24months]
VX1/Volta AF-Xplorer/Volta AF-Xplorer II-related Adverse Event rate.	[24months]

Secondary Outcome Measures

Name	Time	Method
Average number of ablation procedures per patient up to 24 months follow-up.	[24months]
Average number of cardioversions per patient up to 24 months follow-up	[24months]
Serious Adverse Event rate during the post-ablation follow-up period.	[24months]
Progression of Quality-Of-Life score ("EQ-5D-3L") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months).	Preoperative; [24months]
Progression of the AF related symptom score ("EHRA") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months).	Preoperative; [24months]
Health economics analysis including QALY metric.	[24months]
Hospitalization rate during the post-ablation follow-up period.	[24months]
Progression of patient proportion under antiarrhythmic drugs and/or anticoagulant treatments during the study.	[24months]

Trial Locations

Locations (7)

Hôpital Privé Jacques Cartier; 🇫🇷 Massy, France

Polyclinique Saint George; 🇫🇷 Nice, France

Centre Cardiologique du Nord; 🇫🇷 Saint-Denis, France

Clinique Rhéna; 🇫🇷 Strasbourg, France

German Heart Center Munich; 🇩🇪 München, Germany

Hôpital Saint-Joseph; 🇫🇷 Marseille, France

Clinique Pasteur; 🇫🇷 Toulouse, France