Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler (ACTIFER)
ACTIFER
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2021
CompletedFirst Submitted
Initial submission to the registry
November 25, 2021
CompletedFirst Posted
Study publicly available on registry
December 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2022
CompletedDecember 9, 2021
November 1, 2021
1 year
November 25, 2021
November 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
lateral e' speed
measured by tissue Doppler
1 day
Study Arms (1)
Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device
EXPERIMENTALInterventions
trans thoracic echocardiography at the beggining and at the end of the placement of the Saint Jude Medical AMULET type prosthesis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramsay Générale de Santélead
- European Clinical Trial Experts Networkcollaborator
Study Sites (1)
Hôpital Privé Le Bois
Lille, 59000, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2021
First Posted
December 9, 2021
Study Start
September 17, 2021
Primary Completion
September 17, 2022
Study Completion
September 17, 2022
Last Updated
December 9, 2021
Record last verified: 2021-11