AutoMatic disPERsion Tagging Function Preliminary Evaluation (AMPERE)

November 17, 2023 updated by: Volta Medical

Preliminary Evaluation of the Artificial Intelligence Software VX1+ for the Detection and Automatic Tagging on 3D Mapping of Spatio-temporal Dispersion Areas During Atrial Fibrillation or Atrial Tachycardia Ablation Procedures.

Interventional, prospective, non-randomized, single-center, non-controlled clinical investigation as part of the premarket clinical evaluation of VX1+ medical device, aiming to verify that VX1+ in bidirectional configuration with auto-tagging function is both ergonomic and reliable for dispersed electrograms detection and automatic tagging on 3D-map in real-time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ablation of Atrial Fibrillation (AF) and Atrial Tachycardia (AT) is typically performed in predetermined anatomic regions of the left atrium (pulmonary veins isolation) and may be supplemented by a tailored ablation approach in order to identify areas of interest specific to the patient. The VX1+ medical device is intended to assist operators in the manual or automatic real-time annotation of 3D electroanatomical maps of the heart for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatio-temporal dispersion during ablation procedures.

This study will specifically allow to evaluate the peroperative performance of VX1+ automatic tagging function in bi-directional configuration with a compatible 3D mapping system.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Marseille, France, 13008
        • Hôpital Saint-Joseph

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient aged 18 years or older.
  • Patient candidate for catheter ablation of atrial tachycardia, or paroxysmal or persistent atrial fibrillation, de novo or after one or several previous ablation procedures.
  • Continuous anticoagulation for more than 4 weeks before ablation.
  • Patient giving his signed consent form to participate in the clinical study.
  • Patient affiliated to the French social security

Exclusion Criteria:

  • Contraindication to AF/AT catheter ablation.
  • Major bleeding disorder.
  • Contraindication to anticoagulation (Heparin, Warfarin or novel oral anticoagulants (NOAC)) or lack of anticoagulation for 4 weeks prior to the procedure.
  • Presence of a left atrium (LA) thrombus on transesophageal echocardiography (TEE) prior to the procedure.
  • Patient who is or could potentially be pregnant.
  • Person deprived of liberty or under guardianship.
  • Patient's refusal to participate in the study.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atrial mapping and dispersion auto-tagging with VX1+
Device: VX1+ dispersion mapping
Careful biatrial high density dispersion mapping is performed as the first step of the procedure. Operators map each region of both atria carefully by moving the mapping catheter slowly. If VX1+ application detects dispersion regions, the corresponding dipoles location will be automatically tagged on the 3D-map. Accuracy and relevance of dispersion regions should be confirmed by the operator by checking EGMs visually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative reliability of VX1+ in the real-time detection of electrograms in AF or AT exhibiting a spatio-temporal dispersion, and auto-tagging of these dispersion areas on 3D electroanatomical maps.
Time Frame: During procedure
Comparison between the automatically annotated areas with VX1+ and those annotated manually following the operator's visual analysis (true positive, false positive, false negative).
During procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of VX1+ in estimating cardiac cycle lengths
Time Frame: During procedure
Comparison between the cardiac cycle length values estimated by VX1+ and the values measured manually by the operator from the electrograms signals (EGM).
During procedure
Operators' satisfaction regarding the ergonomics of VX1+
Time Frame: Through study completion, assessed up to 4 months
Score of the operator's satisfaction and usage feedbacks regarding the ergonomics of VX1 +
Through study completion, assessed up to 4 months
Preliminary safety data on VX1+ perioperatively in terms of device deficiencies, adverse events and mapping time
Time Frame: From the date of hospitalization for the ablation procedure until the date of discharge, up to 1 week
Rate of device deficiencies during the mapping phase, rate of Adverse Events for the hospitalization period and mapping time of dispersion areas with VX1+ device.
From the date of hospitalization for the ablation procedure until the date of discharge, up to 1 week

Collaborators and Investigators

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

Sponsor

Volta Medical

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)

May 29, 2022

Primary Completion (Actual)

December 9, 2022

Study Completion (Actual)

December 9, 2022

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

April 30, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIPL-03-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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