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AutoMatic disPERsion Tagging Function Preliminary Evaluation

NCT ID: NCT05362656

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-29

Study Completion Date

2022-12-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation Atrial Tachycardia Atrial Arrhythmia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Interventional, prospective, non-randomized, non-controlled, single-center clinical investigation as part of the premarket clinical evaluation of VX1+ (medical device).
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Atrial mapping and dispersion auto-tagging with VX1+

Group Type EXPERIMENTAL

VX1+ dispersion mapping

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Volta Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien SEITZ, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint-Joseph Marseille

Locations

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Hôpital Saint-Joseph

Marseille, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 28104073 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35989543 (View on PubMed)

Lotteau S, Seitz J, Bars C, et al. Bidirectional communication between an artificial intelligence device and a 3-dimensional navigation apparatus improves automation of multipolar electrogram mapping during paroxysmal and persistent atrial fibrillation. Cardiovascular Digital Health Journal. 2023;4(5):S8. doi:10.1016/j.cvdhj.2023.08.017

Reference Type RESULT

Other Identifiers

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CLIPL-03-001

Identifier Type: -

Identifier Source: org_study_id