Pulmonary Vein Ablation Versus Amiodarone in the Elderly (PAVANE)

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: PVI ablation; Drug: Amiodarone

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1091 AC
    • Onze Lieve Vrouwen Gasthuis
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Enschede, Netherlands, 7513 ER
    • Medisch Spectrum Twente
  • Noord Brabant
    • Helmond, Noord Brabant, Netherlands
      • Elkerliek Hospital
    • Veldhoven, Noord Brabant, Netherlands, 5504DB
      • Maxima Medical Center
  • Zuid Holland
    • Den Haag, Zuid Holland, Netherlands, 2545 CH
      • Haga Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PVI ablation; Pulmonary Vein Ablation	Procedure: PVI ablation; Pulmonary Vein Ablation using RF.; Other Names: Pulmonary Vein Isolation
Active Comparator: Amiodarone medical treatment	Drug: Amiodarone; Amiodarone tablets

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Lukas Dekker, Dr, Catharina Ziekenhuis Eindhoven

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: January 11, 2011
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Estimate): December 30, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Efficacy; Elderly patients; PVI ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Amiodarone
• Other Study ID Numbers: AF-10-023-ND-AB