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AutoMatic disPERsion Tagging Function Preliminary Evaluation (AMPERE)

Primary Purpose

Atrial Fibrillation, Atrial Tachycardia, Atrial Arrhythmia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

VX1+ dispersion mapping

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Artificial Intelligence, Cardiac ablation, Medical device, Software, Volta Medical, Atrial Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hôpital Saint-Joseph

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atrial mapping and dispersion auto-tagging with VX1+

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Accuracy of VX1+ in estimating cardiac cycle lengths

Comparison between the cardiac cycle length values estimated by VX1+ and the values measured manually by the operator from the electrograms signals (EGM).

Operators' satisfaction regarding the ergonomics of VX1+

Score of the operator's satisfaction and usage feedbacks regarding the ergonomics of VX1 +

Preliminary safety data on VX1+ perioperatively in terms of device deficiencies, adverse events and mapping time

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.

Full Information

NCT ID

NCT05362656

First Posted

April 27, 2022

Last Updated

February 8, 2023

Sponsor

Volta Medical

1. Study Identification

Unique Protocol Identification Number

NCT05362656

Brief Title

AutoMatic disPERsion Tagging Function Preliminary Evaluation

Acronym

AMPERE

Official 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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

May 29, 2022 (Actual)

Primary Completion Date

December 9, 2022 (Actual)

Study Completion Date

December 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Volta Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Atrial Tachycardia, Atrial Arrhythmia

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atrial mapping and dispersion auto-tagging with VX1+

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

VX1+ dispersion mapping

Intervention Description

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 Outcome Measure Information:

Title

Description

Comparison between the automatically annotated areas with VX1+ and those annotated manually following the operator's visual analysis (true positive, false positive, false negative).

Time Frame

During procedure

Secondary Outcome Measure Information:

Title

Accuracy of VX1+ in estimating cardiac cycle lengths

Description

Comparison between the cardiac cycle length values estimated by VX1+ and the values measured manually by the operator from the electrograms signals (EGM).

Time Frame

During procedure

Title

Operators' satisfaction regarding the ergonomics of VX1+

Description

Score of the operator's satisfaction and usage feedbacks regarding the ergonomics of VX1 +

Time Frame

Through study completion, assessed up to 4 months

Title

Preliminary safety data on VX1+ perioperatively in terms of device deficiencies, adverse events and mapping time

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julien SEITZ, MD

Organizational Affiliation

Hôpital Saint-Joseph Marseille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Saint-Joseph

City

Marseille

ZIP/Postal Code

13008

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28104073

Citation

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.

Results Reference

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PubMed Identifier

35989543

Citation

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.

Results Reference

background

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AutoMatic disPERsion Tagging Function Preliminary Evaluation

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