Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Female Subjects with Recent Onset Atrial Fibrillation or Flutter

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 140

Inclusion Criteria

Subjects may be included in the study only when they meet all of the following criteria:

1. Willing to sign informed consent before screening examinations are performed and before the study drug is administered

2. Female, > 18 years of age

3. Subjects with documented (60 seconds rhythm strip) symptomatic atrial fibrillation or flutter (duration > 3 hours and < 45 days) at the time of randomization

4. Subjects who are in no distress and hemodynamically stable (supine systolic blood
pressure > 90 mmHg and diastolic blood pressure < 105 mmHg)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be excluded from the study for any of the following reasons:

1. Male gender

2. Any woman who is pregnant, lactating, or not using medically acceptable contraception.

3. Evidence of severe hematologic, immunologic, respiratory, urogenital, gastrointestinal, hepatic, renal, endocrinologic, metabolic, nutritional, psychiatric, dermatologic, connective tissue, musculoskeletal, malignant or other relevant disease, allergy or surgery, as revealed by history, physical examination and/or laboratory assessments which may limit participation in or prevent completion of the study

4. Clinical evidence of hyperthyroidism

5. Demonstrated atrial or ventricular thrombus or valvular vegetation during trans-esophageal echocardiogram

6. History of a cerebrovascular accident within six months prior to randomization

7. Congestive heart failure of NYHA functional Class IV

8. History of rheumatic heart disease

9. Acute coronary syndromes at the time of randomization

10. Known history and/or electrocardiographic evidence of ventricular pre-excitation

11. History of life-threatening ventricular arrhythmias including Torsade de Pointes

12. Previous electrocardiographic evidence of second or third degree AV block

13. Sick sinus syndrome

14. Ventricular rate < 50 bpm or > 200 bpm documented by 12-lead ECG

15. Myocardial infarction within 30 days prior to randomization

16. Cardiac surgery within 3 months prior to randomization

17. Need for external and internal pacemaker

18. Stent placement or PTCA within 30 days prior to randomization

19. Congenital long QT syndrome

20. QTc interval > 470 ms prior to randomization.

21. Serum creatinine > 1.8 mg/dl (159 µmol/l)

22. Serum potassium < 4.0 mEq/L (< 4.0 mmol/l)

23. Serum magnesium < 0.8 mmol/L

24. Suspicion or evidence of digitalis intoxication

25. Concurrent treatment with antiarrhythmic drugs (except for digitalis, diltiazem, or ß-blockers), not discontinued for at least five half-lives before randomization. Sotalol is disallowed medication.

26. Treatment with amiodarone within three months prior to randomization

27. Participation in a previous tedisamil clinical study

28. Participation in a clinical trial and/or intake of an investigational drug within four weeks prior to the screening visit.

29. Any history of drug abuse, including alcohol, within one year of screening visit

30. Serious drug allergy or any history of serious abnormal drug reaction

31. Severe valvular heart disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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