AntiPlatelet theraPy stratEgy followiNg left atrial appenDAGe closurE

Phase 1

• Conditions: Atrial Fibrillation, atrial appendage, anticoagulants, stroke, platelet aggregation inhibitors; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-004263-84-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-06
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Male or female patients with LAAC indication according to CNEDiMTS guidelines
- Age = 18 years
- Written informed consent provided by the patient
- Heart team approval: multidisciplinary team including interventional cardiologists, neurologists and other physicians discussing the definitive contraindication for anticoagulation
- Registration under social security system

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Minors
- Unacceptable bleeding risk with double antiplatelet therapy decided by the physician who contraindicated oral anticoagulation
- LAAC contraindication : left appendage thrombus
- Major disease resulting in a life expectancy of < 1 year
- Severe and inherited bleeding disorder
- Known hypersensitivity to aspirin and/or clopidogrel
- Contraindication to MRI: claustrophobia or inability to lie still for exam time, implantable pacemaker or defibrillator, intracorporeal metal foreign body (especially intraocular), intra-ocular metal clipcranial, cochlear implant, cardiac valve prosthesis type Starr-Edwards pre 6000, or biomedical device type insulin pump or neurostimulator.
- Tutorship
- Curatorship
- Pregnancy or child-bearing potential female
- Woman of childbearing age who does not benefit from effective contraception
- Iode contraindication
- Patient already participating in another category 1 interventional research
- Patient in a period of exclusion relative to another research protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified