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

Not Applicable

• Conditions: Left Atrial Closure; Tissue Doppler
• Interventions: Procedure: Trans thoracic echocardiography

• Registration Number: NCT05150366
• Lead Sponsor: Ramsay Générale de Santé

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-17
• Status Verified: 2021-11
• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-11-25
• Last Update Submitted: 2021-11-25
• Study First Posted: 2021-12-09
• Last Update Posted: 2021-12-09
• Primary Completion: 2022-09-17
• Study Completion: 2022-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device	Trans thoracic echocardiography	-

Primary Outcome Measures

Name	Time	Method
lateral e' speed	1 day	measured by tissue Doppler

Trial Locations

Locations (1)

Hôpital Privé Le Bois; 🇫🇷 Lille, France