FindTrial
Sign In

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05150366
Acronym
ACTIFER
Enrollment
48
Registered
2021-12-09
Start date
2021-09-17
Completion date
2022-09-17
Last updated
2021-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tissue Doppler, Left Atrial Closure

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.

Interventions

PROCEDURETrans thoracic echocardiography

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

Sponsors

European Clinical Trial Experts Network
CollaboratorOTHER
Ramsay Générale de Santé
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
lateral e' speed1 daymeasured by tissue Doppler

Countries

France

Contacts

Primary ContactJean-François Oudet
jf.oudet@ecten.eu0683346567
Backup ContactMarie-Hélène Barba
mh.barba@ecten.eu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026