Prospective Registry of Non-vitamin K Antagonist Oral Anticoagulants for ThromboEmbolic Prevention in Adult Patients With Atrial Tachyarrhythmias and Congenital Heart Disease (NOTE)

Rationale: Adult patients with congenital heart disease (CHD) with atrial tachyarrhythmias need to be anticoagulated. It is not known whether non-vitamin K antagonist oral anticoagulants (NOAC) in this patient group are efficient and safe.

Aim: The purpose of the NOTE registry is to evaluate the efficacy and safety of NOACs for thromboembolic prevention in atrial tachyarrhythmia's in adult patients with CHD.

Methods: In this multicenter prospective registry adult CHD patients with atrial tachyarrhythmia's on NOACs will be followed for a period of two years.

Patient population: Registry population consists of CHD patients with tachyarrhythmia's, defined as atrial fibrillation (AF) or atrial tachycardia's (AT), including atrial flutter, on NOACs. Patients with new-onset atrial tachyarrhythmia's who are eligible for NOACs, will be started directly on a NOAC. Patients on vitamin K antagonists (VKA) can be switched actively to NOACs during outpatient clinic visits, in case of agreement of both patient and physician. The switch can be initiated for various reasons, including bleeding complications on VKA, unstable INR measurements, and user friendliness. Eligibility for NOAC use is defined conform clinical practice, i.e. a patient with nonvalvular atrial tachyarrhythmia's, but without a mechanical heart valve, significantly elevated risk of bleeding, impaired renal function, or pregnancy.

Registration process: Patients will be included in the registry at start of NOAC treatment. Exclusion criteria are an expected survival of less than two years and an additional indication for anticoagulation besides atrial tachyarrhythmia's. At baseline general patient characteristics will be registered. Standard echocardiography and laboratory assessments for follow-up in adult CHD patients will be recorded during the registration period. Quality of life and therapy adherence will be assessed with questionnaires. Registry follow-up will be warranted by telephone contact or during outpatient clinic visits. At each follow-up point the occurrence of pre-defined events will be recorded. A detailed description of each variable used by the registry is provided in the protocol. Anonymized data will be collected at each investigational site and entered in a central database at the main investigational site (Academic Medical Center, Amsterdam, The Netherlands).