Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this prospective randomized study is to determine whether patients on cardiac resynchronization therapy with concomitant long-standing persistent or permanent atrial fibrillation would benefit from a strategy to restore and maintain sinus rhythm (rhythm control strategy) in comparison to a rate control strategy in terms of higher biventricular paced beats percentage.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cardiology, Warsaw, Poland
• Treatments: Adrenergic beta-Antagonists; Amiodarone

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