To study the effect of catheter ablation (using CE marked products) on the quality of life an in patients with atrial fibrillation depsite treatment with conevntional antiarrhythmic medical therapy. atrial fibrillation is thus the disease to be investigated MedDRA version: 9.1 Level: LLT Classification code 10066664 Term: Recurrent symptomatic atrial fibrillation
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: SOTALOL HYDROCHLORIDE
CAS Number: 959240
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-160
Pharmaceutical For
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 30-70 years. 2. Patients with symptoms related to AF, who have failed or been intolerant to at least one drug used for either rate or rhythm control (Vaughan Williams class I, II, or III anti-arrhythmic drug) thus excluding digitalis and Ca channel inhibitors. 3. The first diagnosis of AF must have been first noted more than 6 months prior to consideration. 4. At least one AF episode documented on 12-lead ECG or 2-channel telemetry/Holter recording during the previous 12 months. 5. Paroxysmal AF with occurrence of at least one symptomatic episodes (patient history) in the previous 2 months that merits non-pharmacological intervention (see classification), or 6. Persistent AF with occurrence of at least 2 symptomatic episodes of AF in the previous 12 months, necessitating pharmacological or electrical cardioversions (CV), on or off antiarrhythmic drugs that merits non-pharmacological intervention. Upon cardioversion, it must be documented that sinus rhythm can be maintained for at least 1 hour, to distinguish from permanent AF. 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
Exclusion criteria: 1. Patients who have tested 2 or more anti-arrhythmic drugs for rhythm control at highest tolerable dosages (Vaughan Williams class I or III anti-arrhythmic drug. 2. AF secondary to a transient or correctable abnormality . 3. Atrial fibrillation episodes triggered by another uniform SVT. 4. Untreated or uncontrolled hypertension 5. Valvular disease requiring chronic anticoagulation or planned valve surgery within 2 years. 6. Contraindication to treatment with Warfarin or other anticoagulants. 7. Heart failure with NYHA class III or IV or left ventricular ejection fraction ( 60 mm. 9. Unstable angina or acute myocardial infarction within last 3 months. 10. Cardiac revascularization procedure within last 6 months. 11. Prior cardiac surgery or planned cardiac corrective surgery within 1 year. 12. Prior AF ablation procedure 13. ICD, CRT device, Dual chamber- and VVI-pacemaker if needed for VVI pacing, as well as AV block II-III and sustained ventricular tachyarrhythmias. 14. Patients in whom transseptal catheterization or appropriate vascular access is precluded. 15. Renal failure requiring dialysis or abnormalities of liver function tests 16. Participant in investigational clinical or device trial. 17. Pregnant women. 18. Unwilling or unable to give informed consent. 19. Psychological problem that might limit compliance. 20. Active abuse of alcohol or other substance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary hypothesis is that catheter ablation of atrial fibrillation is superior to optimized conventional pharmacological therapy, in improving general health-related quality of life (QoL) at 12 months follow-up, in patients with symptomatic AF. ;Secondary Objective: 6.2 Secondary objectives 1) Quality of life 2) Symptoms 3) Morbidity and mortality as composite outcome (ischemic and hemorrhagic stroke, systemic embolic events, TIA, major bleeding, cardiovascular hospitalizations, pacemaker implantation, all cause death). 4) Cardiovascular hospitalization 5) Successful versus failed treatment 6) Recurrence of episodes of atrial fibrillation 7) AF burden (symptomatic and asymptomatic episodes) 8) Left ventricular heart failure 9) Left ventricular function and diameters 10) Left and right atrial function and diameters 11) Exercise capacity. 12) Health economics 13) AF profile 14) Frequency of withdrawals and change of treatment group over time 15) Further interventions. 16) Safety outcome parameters. Evaluated at 12, 24, 36 and 48 months of follow-up. ;Primary end point(s): general health-related quality of life | — |
Countries
Sweden
Outcome results
None listed