Pulmonary Vein Ablation Versus Amiodarone in the Elderly

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pulmonary Vein Ablation Versus Amiodarone in the Elderly

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: PVI ablation
* Drug: Amiodarone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PVI ablation<br>Pulmonary Vein Ablation | Procedure: PVI ablation<br>* Pulmonary Vein Ablation using RF.<br>* Other names: Pulmonary Vein Isolation;|
| Active Comparator: Amiodarone medical treatment<br>Amiodarone medical treatment | Drug: Amiodarone<br>* Amiodarone tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia |  | Until 1 year after post treatment blanking period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite end point of hospitalization, stroke, major bleeding and death |  | Until last patient has been followed for 15 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, PVI ablation, Elderly patients, Efficacy