Pulmonary Vein Ablation versus Amiodarone in the Elderly

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 135

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Recurrence of episodes of AF, atypical atrial flutter or left sided atrial<br /><br>tachycardia lasting longer than 30 seconds after blanking period in both<br /><br>treatment groups, is considered therapy failure. In the intervention group 2<br /><br>PVI-procedures are allowed. Recurrence of episodes of AF, atypical atrial<br /><br>flutter or left sided atrial tachycardia lasting longer than 30 seconds in an<br /><br>amiodarone intolerant patient is also considered an end point.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Composite end point of hospitalization (cardiac causes, including<br /><br>cardioversion), stroke, major bleedings, death.<br /><br>* Composite end point of recurrence of AF with absence or significant<br /><br>reduction of symptoms not necessitating change of therapy.<br /><br>* Incidence of procedure related and drug related adverse events<br /><br>* Quality of life as measured by SF-36, and AFSS. </p><br>