Pulmonary Vein Ablation Versus Amiodarone in the Elderly (PAVANE)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 ]

Estimated Enrollment: 138
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PVI ablation Procedure: PVI ablation
Pulmonary Vein Ablation using RF.
Active Comparator: 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01276093

Contacts
Contact: Lukas Dekker, Dr +31402397004 lukas.dekker@catharina-ziekenhuis.nl
Contact: Albert Meijer, Dr +31402397004 albert.meijer@catharina-ziekenhuis.nl

Locations
Netherlands
Elkerliek Hospital Recruiting
Helmond, Noord Brabant, Netherlands
Contact: Marga van Gent       mvangent@elkerliek.nl   
Principal Investigator: Paco Prins, PhD         
Maxima Medical Center Recruiting
Veldhoven, Noord Brabant, Netherlands, 5504DB
Contact: Luc Theunissen, PhD       L.Theunissen@mmc.nl   
Principal Investigator: Luc Theunissen, PhD         
Haga Hospital Recruiting
Den Haag, Zuid Holland, Netherlands, 2545 CH
Contact: Vincent Van Driel, PhD       vjhmvandriel@gmail.com   
Principal Investigator: Vincent van Driel, PhD         
Onze Lieve Vrouwen Gasthuis Recruiting
Amsterdam, Netherlands, 1091 AC
Contact: Muchtiar Khan, Dr    +31205999111    m.khan@olvg.nl   
Principal Investigator: Muchtiar Khan, Dr         
Catharina Ziekenhuis Recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: Lukas Dekker, Dr    +31402397004    lukas.dekker@catharina-ziekenhuis.nl   
Principal Investigator: Lukas Dekker, Dr         
Medisch Spectrum Twente Recruiting
Enschede, Netherlands, 7513 ER
Contact: Jeroen Stevenhagen, Dr    +31534872000    Y.stevenhagen@mst.nl   
Principal Investigator: Jeroen Stevenhagen, Dr         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Lukas Dekker, Dr Catharina Hospital Eindhoven
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01276093     History of Changes
Other Study ID Numbers: AF-10-023-ND-AB
Study First Received: January 11, 2011
Last Updated: July 29, 2013
Health Authority: Netherlands: Dutch Health Care Inspectorate

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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on September 22, 2014