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

NCT ID: NCT05150366

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-17

Study Completion Date

2022-09-17

Brief Summary

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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

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Conditions

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Tissue Doppler Left Atrial Closure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Trans thoracic echocardiography

Intervention Type PROCEDURE

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

Interventions

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Trans thoracic echocardiography

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Privé Le Bois

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-François Oudet

Role: CONTACT

Phone: 0683346567

Email: [email protected]

Marie-Hélène Barba

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jean-François Oudet

Role: primary

Other Identifiers

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2020-A02663-36

Identifier Type: -

Identifier Source: org_study_id