Status:
UNKNOWN
AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Atrial Fibrillation
Atrial Appendage
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The APPENDAGE study is a phase 4 multicentre randomized opened clinical trial comparing 2 different antithrombotic strategies following left atrial appendage closure (LAAC) in patients with non valvul...
Detailed Description
Atrial fibrillation (AF) is the most common sustained arrhythmia and increases the risk of ischemic stroke. Although oral anticoagulation (OAC) is recommended in patients with CHADS2VA2SC score ≥ 1, t...
Eligibility Criteria
Inclusion
- Male or female patients with LAAC indication according to "Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé" (CNEDiMTS) (National Commission for the Evaluation of Medical Devices and Health Technologies) 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
Exclusion
- 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:
- Hypersensitivity to clopidogrel, acetylsalicylic acid, or one of the excipients or other nonsteroidal anti-inflammatory drugs (cross-reaction).
- Asthma or a history of asthma with or without nasal polyps induced by salicylates or substances of close activity, including nonsteroidal anti-inflammatory drugs.
- Evolving peptic ulcer or history of gastric hemorrhage or perforation after treatment with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
- Any constitutional or acquired haemorrhagic disease.
- Patients with mastocytosis, in whom the use of acetylsalicylic acid can lead to severe hypersensitivity reactions (including circulatory shocks with flushing, hypotension, tachycardia and vomiting).
- Severe liver failure.
- Severe kidney failure (Creatinine light \< 30ml/min).
- Uncontrolled severe heart failure
- Contraindication to MRI: claustrophobia or inability to lie still for exam time, implantable pacemaker or defibrillator, intracorporeal metal foreign body (especially intraocular), intracranial metal clip, cochlear implant, cardiac valve prosthesis type Starr-Edwards pre 6000, or biomedical device type insulin pump or neurostimulator.
- Guardianship
- Curatorship
- Pregnancy or child-bearing potential female
- Woman of childbearing age who does not benefit from highly effective contraception (CTFG recommendation on highly effective contraceptive methods: oral, intravaginal or transdermal estrogeno-progestin contraception; progestin-based oral, injectable or implantable contraception; intrauterine device; hormonal intrauterine device; female sterilization (occlusion of the fallopian tubes))
- Iode contraindication
- Patient already participating in another category 1 interventional research
- Patient in a period of exclusion relative to another research protocol.
Key Trial Info
Start Date :
October 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 3 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04796714
Start Date
October 3 2022
End Date
May 3 2024
Last Update
October 17 2022
Active Locations (2)
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1
Bordeaux University Hospital
Pessac, France, 33604
2
Toulouse University Hospital
Toulouse, France, 31059