Pulmonary Vein Ablation Versus Amiodarone in the Elderly (PAVANE)

Abbott

Status

Terminated

Conditions

Atrial Fibrillation

Treatments

Procedure: PVI ablation

Drug: Amiodarone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01276093

AF-10-023-ND-AB

Details and patient eligibility

About

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.

Full description

Atrial fibrillation (AF) is the most common arrhythmia. The prevalence of AF is highly age dependent as 70% of AF patients is between 65 and 85 years old. With increasing life expectancy, AF prevalence will increase 2,5 times during the next 50 years and constitute an even more important health concern. In younger patients Pulmonary vein ablation is an accepted procedure with superior efficacy compared to medical treatment. In this study the safety and efficacy of PVI in patients over 70 years old will be evaluated.

Enrollment

59 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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