Clinical Trials Detalhe
Registry on WATCHMAN Outcomes in Real-Life Utilization
Visão Geral
Gender
ALL
Idade
N/A
Fase
N/D
Tipo de Estudo
OBSERVATIONAL
Localização
Hospital de Santa Maria (Lisbon, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT01972282Sumário
The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The objectives of this observational, prospective, non-randomized multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect real-world usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.
Condições
Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
Elegibilidade
Inclusion Criteria: * Patients who are eligible for a WATCHMAN device according to current international and local guidelines (and future revisions) and per physician discretion; * Patient who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center; * Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law. Exclusion Criteria: * Patient who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility; * Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); * The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.