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Atrial FibrillationCOMRADE-AINCT06083012

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

An observational study of Atrial Fibrillation and Atrial Arrhythmia, run by Volta Medical at 7 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cardiac mapping
Type of treatment
Medical device
How many people
186 participants
Where
7 sitesin 2 countries
Study dates
27 Oct 2023to 27 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

France6 sites

  • Hôpital Saint-Joseph

    Marseille, 13008

  • Hôpital Privé Jacques Cartier

    Massy, 91300

  • Polyclinique Saint George

    Nice, 06105

  • Centre Cardiologique du Nord

    Saint-Denis, 93207

  • Clinique Rhéna

    Strasbourg, 67000

  • Clinique Pasteur

    Toulouse, 31000

Other trials in France

Germany1 site

  • German Heart Center Munich

    München, 80636

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Cardiac mapping
Keywords
Artificial Intelligence, Cardiac ablation, Medical device, Software, Volta Medical, Atrial Arrhythmia, VX1, Volta AF-Xplorer, Volta AF-Xplorer II
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac mappingDevice

    Also called Atrial fibrillation mapping, Ablation procedure

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: [24 months]

  2. VX1/Volta AF-Xplorer/Volta AF-Xplorer II-related Incident rate during ablation procedure.

    Measured: [24months]

  3. VX1/Volta AF-Xplorer/Volta AF-Xplorer II-related Adverse Event rate.

    Measured: [24months]

Secondary outcomes (8)

  1. Progression of Quality-Of-Life score ("EQ-5D-3L") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months).

    Measured: Preoperative; [24months]

  2. Progression of the AF related symptom score ("EHRA") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months).

    Measured: Preoperative; [24months]

  3. Hospitalization rate during the post-ablation follow-up period.

    Measured: [24months]

  4. Serious Adverse Event rate during the post-ablation follow-up period.

    Measured: [24months]

  5. Average number of ablation procedures per patient up to 24 months follow-up.

    Measured: [24months]

  6. Average number of cardioversions per patient up to 24 months follow-up

    Measured: [24months]

  7. Progression of patient proportion under antiarrhythmic drugs and/or anticoagulant treatments during the study.

    Measured: [24months]

  8. Health economics analysis including QALY metric.

    Measured: [24months]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2023
  2. Study start27 Oct 2023
  3. Primary completion27 Apr 2027 (estimated)
  4. Study completion27 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06083012
Sponsor's protocol ID
CLIPL-01-004
Acronym
COMRADE-AI
Status last verified
Jan 2026
First submitted
9 Oct 2023
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28104073

  • 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.

    PubMed 35989543

  • 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.

    PubMed 35989539

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Atrial Arrhythmia, run by Volta Medical at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: [24 months]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06083012, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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