AutoMatic disPERsion Tagging Function Preliminary Evaluation (AMPERE)

V

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Atrial mapping and dispersion auto-tagging with VX1+
Experimental group
Treatment:
Device: VX1+ dispersion mapping

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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