Pulmonary Vein Ablation Versus Amiodarone in the Elderly

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of AF.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott Medical Devices; St. Jude Medical
• Treatments: Amiodarone

Criteria

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 ablation.

• Contraindications for amiodarone; 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 rhythm); second or third degree AV-block.

• Contraindications for anti-coagulation: prior life threatening hemorrhage under use of Vitamin K antagonists.

• Any myocardial infarction or PCI in previous 6 months.

• CABG in previous 6 months.

• Renal dysfunction: creatinine clearance <45 ml/min

• Severe co-morbidity. Life expectancy less than 1 year.

• Thrombus in left atrium

• Untreatable allergy to contrast media