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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tissue Doppler; Left Atrial Closure
• Intervention / Treatment: Procedure: Trans thoracic echocardiography

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Recruiting
    • Hôpital Privé Le Bois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device	Procedure: Trans thoracic echocardiography; trans thoracic echocardiography at the beggining and at the end of the placement of the Saint Jude Medical AMULET type prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lateral e' speed	measured by tissue Doppler	1 day

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Anticipated): September 17, 2022
• Study Completion (Anticipated): September 17, 2022

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A02663-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No