The purpose of the study is to demonstrate that in patients of 65 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…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recurrence of episodes of AF, atypical atrial flutter or left sided atrial
tachycardia lasting longer than 30 seconds after blanking period in both
treatment groups, is considered therapy failure. In the intervention group 2
PVI-procedures are allowed. Recurrence of episodes of AF, atypical atrial
flutter or left sided atrial tachycardia lasting longer than 30 seconds in an
amiodarone intolerant patient is also considered an end point.
Secondary outcome
* Composite end point of hospitalization (cardiac causes, including
cardioversion), stroke, major bleedings, death.
* Composite end point of recurrence of AF with absence or significant
reduction of symptoms not necessitating change of therapy.
* Incidence of procedure related and drug related adverse events
* Quality of life as measured by SF-36, and AFSS.
Background summary
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. Treatment
of AF in the elderly is characterized by special challenges. Co-morbid
conditions, degenerative changes of the sinus node and cardiac conduction
system, as well as age-related changes in pharmacokinetics and usage of
multiple drugs are typical in the elderly population. Amiodarone is considered
the most effective anti-arrhythmic drug (AAD) for the prevention of recurrence
of atrial fibrillation. However amiodarone also has numerous and potentially
serious side effects. In the literature on amiodarone for the treatment of
paroxysmal AF up to 18% of patients discontinued amiodarone because of side
effects. PVI through catheter ablation of AF could prove to be a relevant
treatment option in the elderly population. PVI has proven to be a safe and
effective treatment in younger patients with paroxysmal AF. PVI in elder
patients will introduce additional, procedure related risks. The hypothesis in
this trial is that in patients of 65 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.
Study objective
The purpose of the study is to demonstrate that in patients of 65 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.
Study design
Prospective, randomised open label study
Intervention
Pulmonary Vein Isolation using RF catheter ablation
Study burden and risks
Pulmonary Vein Isolation through RF ablation is an accepted treatment for
atrial fibrillation. The additional risk in this study is solely dependent on
the fact that the patient population is at least 65 years of age. All possible
measures to reduce risks of the procedure will be taken. Each participating
investigator/physician will evaluate eligibility of the patients for inclusion
in the study. Several registries on PVI in the elderly have shown that
procedural risk is similar compared to younger patients.
Additional it might be uncomfortable to wear the holter recorder 4 times 7
days. However this does not add any risk for the patient.
The additional vena punctures for blood analysis might give bruises.
The benefit of the study might be that patients of over 65 years could benefit
from PVI ablation and thus reduce the risks associated with AF, provided that
safety and efficacy can be demonstrated in this study.
Standaardruiter 13
Veenendaal 3905 PT
NL
Standaardruiter 13
Veenendaal 3905 PT
NL
Listed location countries
Age
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 PVI ablation.
* Contraindications for amiodarione; 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 rythm); second or third degree AV-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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01276093 |
| CCMO | NL35318.060.11 |