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

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: PVI ablation Drug: Amiodarone Not Applicable

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  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pulmonary Vein Ablation Versus Amiodarone in the Elderly
Study Start Date : July 2011
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia [ Time Frame: Until 1 year after post treatment blanking period ]

Secondary Outcome Measures :
  1. Composite end point of hospitalization, stroke, major bleeding and death [ Time Frame: Until last patient has been followed for 15 months after inclusion ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Ziekenhuis Eindhoven

Responsible Party: St. Jude Medical Identifier: NCT01276093     History of Changes
Other Study ID Numbers: AF-10-023-ND-AB
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

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