Pulmonary Vein Ablation Versus Amiodarone in the Elderly (PAVANE)

This study is currently recruiting participants.
Verified July 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01276093
First received: January 11, 2011
Last updated: July 29, 2013
Last verified: July 2013

January 11, 2011
July 29, 2013
July 2011
December 2014   (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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01276093 on ClinicalTrials.gov 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 ] [ Designated as safety issue: Yes ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • Procedure: PVI ablation
    Pulmonary Vein Ablation using RF.
  • Drug: Amiodarone
    Amiodarone tablets
  • Experimental: PVI ablation
    Intervention: Procedure: PVI ablation
  • Active Comparator: Amiodarone medical treatment
    Intervention: Drug: Amiodarone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
138
December 2015
December 2014   (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
Both
65 Years and older
No
Contact: Lukas Dekker, Dr +31402397004 lukas.dekker@catharina-ziekenhuis.nl
Contact: Albert Meijer, Dr +31402397004 albert.meijer@catharina-ziekenhuis.nl
Netherlands
 
NCT01276093
AF-10-023-ND-AB
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Lukas Dekker, Dr Catharina Hospital Eindhoven
St. Jude Medical
July 2013

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