Statistical consultant won’t be aware about what therapy has been assigned in the different subjects so the bias will be reduced.
h. Interventions
The main objective of this study is to compare free AF burden after CB ablation and AADs in treating patients with paroxysmal AF as a first-line treatment. One treatment group will receive the intervention A: CB ablation. Meanwhile, the other treatment group will receive the intervention B: AADs. …show more content…
First of all, the patients will be asked to participate in the study. In case of acceptance, an information sheet will be given (Annex A) to inform about the procedures, risks and benefits. After that, information consent (Annex B) will be given to him and randomization will start.
Each participant will be assigned according to a code (VII.f Randomization). On the one hand, if the patients are chosen to be in the non-operative group; the subjects will be refer to a cardiologist and start AADs medication. On the other hand, if operative treatment is chosen, the doctor will inform to the interventional cardiologist and the patient will be informed with more detail and she/he will be asked to sign the procedure consent (Annexed