The purpose of this study is to assess the efficacy of F373280 on the maintenance of normal cardiac rhythm after direct electric cardioversion in patients with persistent atrial fibrillation and cardiac failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
135
Oral administration, one capsule each evening with dinner.
Oral administration, one capsule each evening with dinner.
Unnamed facility
Karlovy Vary, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Praha 5 - Motol, Czechia
Time to First Atrial Fibrillation (AF) Recurrence or Atrial Flutter Emergence Defined by the Time to First Episode of AF or Atrial Flutter Lasting for at Least 10 Minutes During the 20-week Follow-up After Visit 3 (Electrical Cardioversion (ECV) Visit).
Time to first Atrial Fibrillation (AF) recurrence defined by the first episode of Atrial Fibrillation lasting for at least 10 minutes. AF recurrences or atrial flutter emergences: 7-day continuous electrocardiogram (ECG; 5-leads/2 or 3 channels) ambulatory recording (Holter ECG) between Visit 3 (Electrical Cardioversion Visit) and Visit 4 (Week 5). Then, the follow-up was documented using the Transtelephonic ECG monitor (TTEM): one transmission every two days from Week 9 to Week 24. For randomised patients with spontaneous cardioversion before Electrical Cardioversion, the recurrence of AF or the emergence of atrial flutter was assessed after Visit 3 (from Week 5). Moreover, during this TTEM period, if the patient experienced any AF or atrial flutter symptoms, it was recorded and documented using the TTEM.
Time frame: from electrical cardioversion (Visit 3) to last follow-up visit (W24)
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Unnamed facility
Budapest, Hungary
Unnamed facility
Budapest, Hungary
Unnamed facility
Budapest, Hungary
Unnamed facility
Budapest, Hungary
Unnamed facility
Augusta, Italy
Unnamed facility
Brescia, Italy
Unnamed facility
Foggia, Italy
...and 10 more locations