NCT06083012

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
2 countries

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Oct 2023Apr 2027

First Submitted

Initial submission to the registry

October 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

October 27, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

October 9, 2023

Last Update Submit

January 14, 2026

Conditions

Atrial FibrillationAtrial ArrhythmiaArrhythmias, Cardiac

Keywords

Artificial IntelligenceCardiac ablationMedical deviceSoftwareVolta MedicalAtrial ArrhythmiaVX1Volta AF-XplorerVolta AF-Xplorer II

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • 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]

  • +3 more secondary outcomes

Interventions

Cardiac mappingDEVICE

All patients enrolled are treated for their atrial fibrillation/tachycardia via a catheter ablation procedure using VX1/Volta AF-Xplorer/Volta AF-Xplorer II 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.

Also known as: Atrial fibrillation mapping, Ablation procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patient candidate eligible 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.

You may qualify if:

  • 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 or Volta AF-Xplorer or Volta AF-Xplorer II.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hôpital Saint-Joseph

Marseille, 13008, France

Location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

Polyclinique Saint George

Nice, 06105, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93207, France

Location

Clinique Rhéna

Strasbourg, 67000, France

Location

Clinique Pasteur

Toulouse, 31000, France

Location

German Heart Center Munich

München, 80636, Germany

Location

Related Publications (3)

  • 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.

    PMID: 28104073BACKGROUND

  • 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.

    PMID: 35989543BACKGROUND

  • 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.

    PMID: 35989539BACKGROUND

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Julien SEITZ, MD

    Hôpital Saint Joseph Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 13, 2023

Study Start

October 27, 2023

Primary Completion (Estimated)

April 27, 2027

Study Completion (Estimated)

April 27, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)DE(1)