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

NCT05150366 | Completed

• 1 other identifier: 2020-A02663-36
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tissue Doppler; Left Atrial Closure

Outcome Measures

Primary Outcomes (1)

• lateral e' speed

  measured by tissue Doppler

  1 day

Study Arms (1)

Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device

EXPERIMENTAL

Procedure: Trans thoracic echocardiography

Interventions

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

Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Clinical Trial Experts Network: collaborator
• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Le Bois

Lille, 59000, France

Location

Study Design

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

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 9, 2021
• Study Start: September 17, 2021
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

FR (1)