Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pulmonary Vein Ablation Versus Amiodarone in the Elderly (PAVANE)

This study has been terminated.
(DSMB recommendation; enrollment too slow)
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: January 11, 2011
Last updated: December 28, 2015
Last verified: December 2015
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.

Condition Intervention
Atrial Fibrillation
Procedure: PVI ablation
Drug: Amiodarone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulmonary Vein Ablation Versus Amiodarone in the Elderly

Resource links provided by NLM:

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 59
Study Start Date: July 2011
Estimated Study Completion Date: March 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PVI ablation
Pulmonary Vein Ablation
Procedure: PVI ablation
Pulmonary Vein Ablation using RF.
Other Name: Pulmonary Vein Isolation
Active Comparator: Amiodarone medical treatment
Amiodarone medical treatment
Drug: Amiodarone
Amiodarone tablets

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.

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01276093

Elkerliek Hospital
Helmond, Noord Brabant, Netherlands
Maxima Medical Center
Veldhoven, Noord Brabant, Netherlands, 5504DB
Haga Hospital
Den Haag, Zuid Holland, Netherlands, 2545 CH
Onze Lieve Vrouwen Gasthuis
Amsterdam, Netherlands, 1091 AC
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Medisch Spectrum Twente
Enschede, Netherlands, 7513 ER
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Lukas Dekker, Dr Catharina Hospital Eindhoven
  More Information

Responsible Party: St. Jude Medical Identifier: NCT01276093     History of Changes
Other Study ID Numbers: AF-10-023-ND-AB 
Study First Received: January 11, 2011
Last Updated: December 28, 2015
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by St. Jude Medical:
Atrial fibrillation
PVI ablation
Elderly patients

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors processed this record on October 25, 2016