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

Sponsor

Volta Medical (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06083012

Collaborator

Fortrea (Other)

150

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

All patients enrolled are treated for their 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 his 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 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 his last annual visit at 24 months post-ablation index.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Atrial Arrhythmia Arrhythmias, Cardiac	Device: Cardiac mapping

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2023

Anticipated Primary Completion Date :

Oct 15, 2026

Anticipated Study Completion Date :

Oct 15, 2026

Outcome Measures

Primary Outcome Measures

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-related Incident rate during ablation procedure. [[24months]]
VX1-related Adverse Event rate. [[24months]]

Secondary Outcome Measures

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]]
Hospitalization rate during the post-ablation follow-up period. [[24months]]
Serious Adverse Event rate during the post-ablation follow-up period. [[24months]]
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]]
Progression of patient proportion under antiarrhythmic drugs and/or anticoagulant treatments during the study. [[24months]]
Health economics analysis including QALY metric. [[24months]]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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's refusal to participate in the study.
Enrollment in an investigational study evaluating another device, biologic, or drug.