Pulmonary Vein Ablation Versus Amiodarone in the Elderly (PAVANE)
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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 |
- 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 ]
- 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 2014 |
| Estimated Primary Completion Date: | December 2013 (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: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 70 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 or pacemaker.
- 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); second or third degree AV-block; left bundle branch block.
- Contraindications for anti-coagulation: prior life threatening hemorrhage under use of Vitamine K antagonists.
- Any myocardial infarction or PCI in previous 6 months.
- CABG in previous 6 months.
- Renal dysfunction: creatinin 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| Contact: Lukas Dekker, Dr | +31402397004 | lukas.dekker@catharina-ziekenhuis.nl |
| Contact: Albert Meijer, Dr | +31402397004 | albert.meijer@catharina-ziekenhuis.nl |
| Netherlands | |
| 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 | |
| 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: | August 20, 2012 |
| 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 May 21, 2013