Pulmonary Vein Ablation versus Amiodarone in the Elderly - PAVANE

St. Jude Medical0 个研究点目标入组 135 人开始时间: 待定最近更新: 2024年4月29日

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•* Age * 65 years at moment of screening, able to sign informed consent.
•* Documented paroxysmal AF in association with complaints in the last year, with at least 2 episodes of complaints attributed to AF in the previous 2 months.
•* Paroxysmal AF documented with at least one ECG with sinus rhythm not after cardioversion in the last year.
•* No prior use of amiodarone in the last 6 months and no usage longer than 4 weeks in total.

•* EF < 35 % or description of *poor left ventricular function* on echocardiogram. Measurement should not be older than 6 months at moment of screening.
•* Aortic ,mitral, pulmonary or tricuspid valve regurgitation or stenosis, if graded severe (grade >3).
•* Acute illness: unstable angina, infectious disease.
•* Primary structural or electrical heart disease: dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome, long QT syndrome.
•* Reversible causes (thyroid dysfunction, uncontrolled hypertension, ischemia).
•* Previous PVI ablation.
•* Contraindications for amiodarione; liver dysfunction (serum alanine aminotransferase >2.5 times upper limit); thyroid dysfunction; chronic lung disease; baseline QTc >460 ms. sinus node dysfunction (pause more than 3 seconds in sinus rythm); second or third degree AV-block.
•* Contraindications for anti-coagulation: prior life threatening hemorrhage under use of Vitamine K antagonists.
•* Any myocardial infarction or PCI in previous 6 months.
•* CABG in previous 6 months.
•* Renal dysfunction: creatinin clearance <45 ml/min
•* Severe co-morbidity. Life expectancy less than 1 year.
•* Thrombus in left atrium
•* Untreatable allergy to contrast media

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