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OpenTrials
Completed

NCT Number: NCT05150366

Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler (AURIFER)

The main objective is to demonstrate the equivalence, before and after the percutaneous closure of the left atrial procedure, of the maximum proto-diastolic velocity of the lateral mitral annulus (e 'lat) measured by tissue Doppler. Patients with AF at high embolic risk and presenting a formal and definitive contraindication to anticoagulants having been operated on for percutaneous closure of the left atrial by St Jude AMULET device, considering an equivalence margin of 1 cm / sec.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Le Bois

Lille, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Man or woman over 18 years-old
  • Patient with paroxysmal AF at high embolic risk (CHA2DS2Vasc score ≥ 4) and presenting a formal and definitive contraindication to anticoagulants
  • Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device
  • Patient in sinus rhythm
  • Subject affiliated or beneficiary of a social security scheme
  • Patient having signed the informed consent

Exclusion criteria

  • Patient participating in another clinical study
  • Patient in permanent ACFA
  • Patient with a mitral prosthesis (biological or mechanical),
  • Patient with a history of mitral annuloplasty
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
  • Pregnant, breastfeeding or parturient woman;
  • Patient hospitalized without consent.

Treatment and study plan

Trans thoracic echocardiography

Procedure

trans thoracic echocardiography at the beggining and at the end of the placement of the Saint Jude Medical AMULET type prosthesis

Primary outcomes

  1. lateral e' speed

    Time frame: 1 day

    measured by tissue Doppler

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • European Clinical Trial Experts Network

Registry information

Official study title

Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler

Acronym: AURIFER

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2021
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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