Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study (Pilot-CRAfT)
Atrial Fibrillation, Heart Failure
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Cardiac resynchronization therapy, Heart failure, Rhythm control strategy
Eligibility Criteria
Inclusion Criteria:
- Permanent or long-standing persistent atrial fibrillation (definitions according to the latest European Society of Cardiology guidelines on AF)
- At least 3 months after a procedure of a CRT device implantation
- A CRT device with a presence of a right atrial electrode
- Age: ≥18 years old
- Effectively biventricular paced captured beats <95%
- Effective therapy with oral anticoagulants for at least 3 months
- Written informed consent
Exclusion Criteria:
- Reversible causes of AF
- Significant valve disease
- Advanced A-V block (including: AVJA)
- Contraindications to amiodarone (hyperthyroidism, not compensated hypothyroidism, drug intolerance, QT>460ms for men, QT>450 for women)
- Long-QT syndrome
- Decompensation of the heart failure within 48 hours before the qualification
- Cardiac transplantation in 6 months
- Life expectancy less than 1 year
- Chronic dialysis
- LA diameter >6cm
- Alcohol abuse
- Pregnancy/lack of effective contraceptive therapy (in case of females in the reproductive age)
- Participation in other clinical trial
Sites / Locations
- Institute of Cardiology, II Dept. of Coronary Heart DiseaseRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rhythm control
Rate control
In this group a strategy to restore and maintain SR, including amiodarone and an external electrical cardioversion (EEC), is implemented. A procedure of AF ablation is possible but not obligatory. At baseline, patients assigned to the group undergo a standard 12-lead ECG, a 6-minute walk test (6MWT), a cardiopulmonary exercise test(CPX), an echocardiography(ECHO), a standard device control; a serum thyroid -stimulating hormone (TSH) level is assessed and patients fill the Minnesota Living With Heart Failure Questionnaire (MLHFQ). Control visits are performed every 3 months including a 12-lead ECG measurement and a device control. On the visits in the 3rd and 12th month an ECHO, a CPX, a 6MWT are performed and a MLHFQ is filled; control TSH levels are assessed every 6 months.
In the latter group a pharmacotherapy to slow and control ventricular rate by means of pharmacotherapy and an atrio-ventricular junction ablation (AVJA) is implemented. At baseline, each patient assigned to the rate control group undergoes a standard 12-lead ECG, a 6MWT, a CPX, an ECHO, a standard device control and a serum TSH level assessed. Moreover, the patient fills the Minnesota Living With Heart Failure Questionaire (MLHFQ). The control visits are performed for one year, every 3 months including a standard 12-lead ECG measurement and standard control of the device. On the visits in the 3rd and 12th month additionally an ECHO, a CPX, a 6MWT are performed and a MLHFQ is filled. The control TSH levels are assessed every 6 months.