Pulmonary Vein Ablation Versus Amiodarone in the Elderly

Atrial Fibrillation Clinical Trial

— PAVANE  

Official title:

Pulmonary Vein Ablation Versus Amiodarone in the Elderly

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01276093
• Other study ID #: AF-10-023-ND-AB
• Status: Terminated
• Phase: N/A
• First received: January 11, 2011
• Last updated: December 28, 2015
• Start date: July 2011
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: St. Jude Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• PVI ablation
Pulmonary Vein Ablation using RF.

Drug:
• Amiodarone
Amiodarone tablets

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwen Gasthuis	Amsterdam
Netherlands	Haga Hospital	Den Haag	Zuid Holland
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Elkerliek Hospital	Helmond	Noord Brabant
Netherlands	Maxima Medical Center	Veldhoven	Noord Brabant

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Medical

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia		Until 1 year after post treatment blanking period	No
Secondary	Composite end point of hospitalization, stroke, major bleeding and death		Until last patient has been followed for 15 months after inclusion	Yes