Pulmonary Vein Ablation Versus Amiodarone in the Elderly

NCT ID: NCT01276093

Last Updated: 2015-12-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2016-03-31

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; PVI ablation; Elderly patients; Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PVI ablation

Pulmonary Vein Ablation

Group Type: EXPERIMENTAL

PVI ablation

Intervention Type: PROCEDURE

Pulmonary Vein Ablation using RF.

Amiodarone medical treatment

Amiodarone medical treatment

Group Type: ACTIVE_COMPARATOR

Amiodarone

Intervention Type: DRUG

Amiodarone tablets

Interventions

PVI ablation

Pulmonary Vein Ablation using RF.

Intervention Type: PROCEDURE

Amiodarone

Amiodarone tablets

Intervention Type: DRUG

Other Intervention Names

Pulmonary Vein Isolation

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lukas Dekker, Dr

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Elkerliek Hospital

Helmond, North Brabant, Netherlands

Maxima Medical Center

Veldhoven, North Brabant, Netherlands

Haga Hospital

The Hague, South Holland, Netherlands

Onze Lieve Vrouwen Gasthuis

Amsterdam, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

Countries

Netherlands

Other Identifiers

AF-10-023-ND-AB

Identifier Type: -

Identifier Source: org_study_id