Clinical trial NCT01276093: Pulmonary Vein Ablation Versus Amiodarone in the Elderly
Official title: Pulmonary Vein Ablation Versus Amiodarone in the Elderly
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
PVI ablation
Elderly patients
Efficacy
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 59
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia
timeFrame: Until 1 year after post treatment blanking period
Secondary outcomes:
measure: Composite end point of hospitalization, stroke, major bleeding and death
timeFrame: Until last patient has been followed for 15 months after inclusion
Other outcomes:
Locations:
city: Helmond
country: Netherlands
facility: Elkerliek Hospital
state: Noord Brabant
city: Veldhoven
country: Netherlands
facility: Maxima Medical Center
state: Noord Brabant
city: Den Haag
country: Netherlands
facility: Haga Hospital
state: Zuid Holland
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwen Gasthuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Lukas Dekker, Dr
role: PRINCIPAL_INVESTIGATOR
References: