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

R

Ramsay Générale de Santé

Status

Unknown

Conditions

Left Atrial Closure
Tissue Doppler

Treatments

Procedure: Trans thoracic echocardiography

Study type

Interventional

Funder types

Other

Identifiers

NCT05150366
2020-A02663-36

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device
Experimental group
Treatment:
Procedure: Trans thoracic echocardiography

Trial contacts and locations

1

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Central trial contact

Jean-François Oudet; Marie-Hélène Barba

Data sourced from clinicaltrials.gov

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