Status:
UNKNOWN
Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study
Lead Sponsor:
National Institute of Cardiology, Warsaw, Poland
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Due to a lack of sufficient data the present guidelines on treatment of patients with atrial fibrillation (AF) and cardiac resynchronization therapy (CRT) devices are of low scientific evidence. The e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01850277
Start Date
October 1 2013
End Date
March 1 2017
Last Update
March 10 2015
Active Locations (1)
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1
Institute of Cardiology, II Dept. of Coronary Heart Disease
Warsaw, Poland, 02-637