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

Atrial Fibrillation Clinical Trial

— COMRADE-AI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083012
• Other study ID #: CLIPL-01-004
• Status: Recruiting
• Start date: October 27, 2023
• Est. completion date: October 27, 2026

Study information

• Verified date: November 2023
• Source: Volta Medical
• Contact: Paola MILPIED
• Phone: +33768025499
• Email: paola.milpied[@]volta-medical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 27, 2026
• Est. primary completion date: October 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Arrhythmia
• Atrial Fibrillation

Intervention

Device:
• Cardiac mapping
All patients enrolled are treated for their atrial fibrillation/tachycardia via a catheter ablation procedure using VX1 software (used in accordance with its approved indication as per of its IFU) 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. The two main phases of the ablation procedure are: 3D mapping of the atria and location of areas of interest; Catheter ablation at the operator's discretion.

Locations

Country	Name	City	State
France	Hôpital Saint-Joseph	Marseille
France	Clinique Pasteur	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Volta Medical	Fortrea

Country where clinical trial is conducted

France, 

References & Publications (3)

Deisenhofer I. Electrogram-based AF ablation: finally, reproducibility! J Cardiovasc Electrophysiol. 2022 Nov;33(11):2261-2262. doi: 10.1111/jce.15660. Epub 2022 Sep 18. No abstract available. — View Citation

Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065. — View Citation

Seitz J, Durdez TM, Albenque JP, Pisapia A, Gitenay E, Durand C, Monteau J, Moubarak G, Theodore G, Lepillier A, Zhao A, Bremondy M, Maluski A, Cauchemez B, Combes S, Guyomar Y, Heuls S, Thomas O, Penaranda G, Siame S, Appetiti A, Milpied P, Bars C, Kalifa J. Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2022 Nov;33(11):2250-2260. doi: 10.1111/jce.15657. Epub 2022 Sep 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	VX1-related Incident rate during ablation procedure.		[24months]
Primary	VX1-related Adverse Event rate.		[24months]
Secondary	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]
Secondary	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]
Secondary	Hospitalization rate during the post-ablation follow-up period.		[24months]
Secondary	Serious Adverse Event rate during the post-ablation follow-up period.		[24months]
Secondary	Average number of ablation procedures per patient up to 24 months follow-up.		[24months]
Secondary	Average number of cardioversions per patient up to 24 months follow-up		[24months]
Secondary	Progression of patient proportion under antiarrhythmic drugs and/or anticoagulant treatments during the study.		[24months]
Secondary	Health economics analysis including QALY metric.		[24months]