Table I.
Data collected | Visit 0 | Visit 1 (12 mo) |
Visit 2 (24 mo) |
---|---|---|---|
Informed consent | X | – | – |
Medical history and physical examination | X | X | X |
ECG | X | X* | X* |
Echocardiography | X | X | X |
Assessment for outcome events | – | X | X |
Blood tests | X† | – | – |
Performance of ECGs at each follow-up visit is not mandated by the protocol, but data will be collected if done as part of routine practice.
Include hemogram, basic biochemistry, and INR; performance of blood investigations are not mandated by the protocol, but data will be collected if tests are done as part of routine practice.