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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06083012
Other study ID # CLIPL-01-004
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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]
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