Pulmonary Vein Ablation Versus Amiodarone in the Elderly (PAVANE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01276093
Recruitment Status : Terminated (DSMB recommendation; enrollment too slow)
First Posted : January 13, 2011
Last Update Posted : December 30, 2015
Information provided by (Responsible Party):
St. Jude Medical

January 11, 2011
January 13, 2011
December 30, 2015
July 2011
December 2015   (Final data collection date for primary outcome measure)
Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia [ Time Frame: Until 1 year after post treatment blanking period ]
Same as current
Complete list of historical versions of study NCT01276093 on Archive Site
Composite end point of hospitalization, stroke, major bleeding and death [ Time Frame: Until last patient has been followed for 15 months after inclusion ]
Same as current
Not Provided
Not Provided
Pulmonary Vein Ablation Versus Amiodarone in the Elderly
Pulmonary Vein Ablation Versus Amiodarone in the Elderly
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Atrial Fibrillation
  • Procedure: PVI ablation
    Pulmonary Vein Ablation using RF.
    Other Name: Pulmonary Vein Isolation
  • Drug: Amiodarone
    Amiodarone tablets
  • Experimental: PVI ablation
    Pulmonary Vein Ablation
    Intervention: Procedure: PVI ablation
  • Active Comparator: Amiodarone medical treatment
    Amiodarone medical treatment
    Intervention: Drug: Amiodarone
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2016
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Lukas Dekker, Dr Catharina Ziekenhuis Eindhoven
St. Jude Medical
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP