Pulmonary Vein Ablation Versus Amiodarone in the Elderly (PAVANE)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PVI ablation
Amiodarone
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, PVI ablation, Elderly patients, Efficacy
Eligibility 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
Sites / Locations
- Elkerliek Hospital
- Maxima Medical Center
- Haga Hospital
- Onze Lieve Vrouwen Gasthuis
- Catharina Ziekenhuis
- Medisch Spectrum Twente
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PVI ablation
Amiodarone medical treatment
Arm Description
Pulmonary Vein Ablation
Amiodarone medical treatment
Outcomes
Primary Outcome Measures
Recurrence of episodes of AF, atypical atrial flutter or left sided atrial tachycardia
Secondary Outcome Measures
Composite end point of hospitalization, stroke, major bleeding and death
Full Information
NCT ID
NCT01276093
First Posted
January 11, 2011
Last Updated
December 28, 2015
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT01276093
Brief Title
Pulmonary Vein Ablation Versus Amiodarone in the Elderly
Acronym
PAVANE
Official Title
Pulmonary Vein Ablation Versus Amiodarone in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
DSMB recommendation; enrollment too slow
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, PVI ablation, Elderly patients, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PVI ablation
Arm Type
Experimental
Arm Description
Pulmonary Vein Ablation
Arm Title
Amiodarone medical treatment
Arm Type
Active Comparator
Arm Description
Amiodarone medical treatment
Intervention Type
Procedure
Intervention Name(s)
PVI ablation
Other Intervention Name(s)
Pulmonary Vein Isolation
Intervention Description
Pulmonary Vein Ablation using RF.
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Intervention Description
Amiodarone tablets
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Composite end point of hospitalization, stroke, major bleeding and death
Time Frame
Until last patient has been followed for 15 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukas Dekker, Dr
Organizational Affiliation
Catharina Ziekenhuis Eindhoven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elkerliek Hospital
City
Helmond
State/Province
Noord Brabant
Country
Netherlands
Facility Name
Maxima Medical Center
City
Veldhoven
State/Province
Noord Brabant
ZIP/Postal Code
5504DB
Country
Netherlands
Facility Name
Haga Hospital
City
Den Haag
State/Province
Zuid Holland
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Onze Lieve Vrouwen Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
12. IPD Sharing Statement
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Pulmonary Vein Ablation Versus Amiodarone in the Elderly
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