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

November 21, 2023 updated by: Volta Medical
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Marseille, France, 13008
      • Toulouse, France, 31000
        • Recruiting
        • Clinique Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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]
[24 months]
VX1-related Incident rate during ablation procedure.
Time Frame: [24months]
[24months]
VX1-related Adverse Event rate.
Time Frame: [24months]
[24months]

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression of Quality-Of-Life score ("EQ-5D-3L") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months).
Time Frame: Preoperative; [24months]
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).
Time Frame: Preoperative; [24months]
Preoperative; [24months]
Hospitalization rate during the post-ablation follow-up period.
Time Frame: [24months]
[24months]
Serious Adverse Event rate during the post-ablation follow-up period.
Time Frame: [24months]
[24months]
Average number of ablation procedures per patient up to 24 months follow-up.
Time Frame: [24months]
[24months]
Average number of cardioversions per patient up to 24 months follow-up
Time Frame: [24months]
[24months]
Progression of patient proportion under antiarrhythmic drugs and/or anticoagulant treatments during the study.
Time Frame: [24months]
[24months]
Health economics analysis including QALY metric.
Time Frame: [24months]
[24months]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Volta Medical

Collaborators

Fortrea

Investigators

  • Principal Investigator: Julien SEITZ, MD, Hôpital Saint Joseph Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2023

Primary Completion (Estimated)

October 27, 2026

Study Completion (Estimated)

October 27, 2026

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIPL-01-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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