AutoMatic disPERsion Tagging Function Preliminary Evaluation (AMPERE)

Volta Medical

Status

Completed

Conditions

Atrial Tachycardia

Atrial Fibrillation

Atrial Arrhythmia

Treatments

Device: VX1+ dispersion mapping

Study type

Interventional

Funder types

Industry

Identifiers

NCT05362656

CLIPL-03-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.