AutoMatic disPERsion Tagging Function Preliminary Evaluation

NCT05362656 | Completed

• 1 other identifier: CLIPL-03-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Atrial Tachycardia; Atrial Arrhythmia

Keywords

Artificial Intelligence; Cardiac ablation; Medical device; Software; Volta Medical; Atrial Arrhythmia

Outcome Measures

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.

  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 Outcomes (3)

• Accuracy of VX1+ in estimating cardiac cycle lengths

  During procedure

• Operators' satisfaction 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

  From the date of hospitalization for the ablation procedure until the date of discharge, up to 1 week

Study Arms (1)

Atrial mapping and dispersion auto-tagging with VX1+

EXPERIMENTAL

Device: VX1+ dispersion mapping

Interventions

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.

Atrial mapping and dispersion auto-tagging with VX1+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Volta Medical: lead

Study Sites (1)

Hôpital Saint-Joseph

Marseille, 13008, France

Location

Related Publications (3)

• 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.

  PMID: 28104073 BACKGROUND

• 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.

  PMID: 35989543 BACKGROUND

• 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

  RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julien SEITZ, MD

  Hôpital Saint-Joseph Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 5, 2022
• Study Start: May 29, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)