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OpenTrials
Completed

NCT Number: NCT05362656

AutoMatic disPERsion Tagging Function Preliminary Evaluation

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint-Joseph

Marseille, 13008, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX1+ dispersion mapping

Device

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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 +

  3. 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.

Sponsors and collaborators

Lead sponsor

Volta Medical

Industry

Registry information

Official study title

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.

Acronym: AMPERE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 5, 2022
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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