Informations générales (source: ClinicalTrials.gov)

NCT05150366 Statut inconnu
Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler
Interventional
N/A
Ramsay Générale de Santé (Voir sur ClinicalTrials)
septembre 2021
septembre 2022
09 mai 2026
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.

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hôpital Privé Le Bois - 59000 - Lille - France Jean-François Oudet En recrutement Contact (sur clinicalTrials)

Critères

Tous


- 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.