Purpose is to show that multi-electrode ablation is not inferior to irrigated single tip catheter ablation guided by 3-D mapping to treat paroxysmal atrial fibrillation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary effectiveness endpoint for the study is
-absence of symptomatic atrial fibrillation
-and freedom from secondary atrial arrhythmias at 3, 6 and 12 months
post-procedure by:
· Repeated ECG
· repeated 48-hour Holter in asymptomatic patients
· event-recorder in symptomatic patients.
The safety endpoint is the measurement of a composite list of
procedure and device related serious adverse events followed for seven days.
SAEs will include:
· Stroke· Major bleeding requiring surgical intervention
· Cardiac tamponade· PV stenosis· Myocardial infarction
· Diaphragmatic paralysis
· Atrio-esophageal fistula
· Death
Secondary outcome
Secondaire effectiviteits eindpunten:
- Improvement of symptoms after 3 and 12 month
- Duration of RF burden
- Skin-skin time for the ablation procedure
- Fluoroscopy time
Background summary
Atrial fibrillation (AF) is a very common cardiac arrhythmia affecting more
than 8 million people in the US and Europe with still growing numbers. AF is
associated with a 2.5 fold increase in mortality, and significant. Drugs have
been found effective in no more than 60% of patients., regardless of whether a
rate- or rhythm-control strategy was chosen. In symptomatic patients catheter
ablation has become an accepted second line therapy. For paroxysmal AF efficacy
rates of over 80% have been reported. The standard accepted technique nowadays
is circumferential ablation in the antrum of the pulmonary veins (PVs) to
achieve electrical isolation. This procedure is time consuming and the creation
of lesions, which may add up to 50-100 point by point applications, is
difficult and slow. Recently, a novel technology has been introduced that uses
multi-electrode catheter technology for PV isolation. The procedure may be
performed with only 2 catheters. In a single center study, the procedure was
found to have an 83% efficacy and procedure times appeared to be much shorter
than with conventional technology.
Study objective
Purpose is to show that multi-electrode ablation is not inferior to irrigated
single tip catheter ablation guided by 3-D mapping to treat paroxysmal atrial
fibrillation.
Study design
Prospective, multicenter-, multinational, randomised, non-inferiority trial
with two groups.
Intervention
Catheterablation with either the multi-electrode PVAC catheter, or the
single-tip catheter
Study burden and risks
Participation in this study will not increase additional burden to the patient
and will not lead to benefit. After the ablation procedure the patient will
have 1 additional visits to the outpatient clinic and will undergo 1 additional
holter recording 12 months after ablation
Koekoekslaan 1
3435 cm
NL
Koekoekslaan 1
3435 cm
NL
Listed location countries
Age
Inclusion criteria
1.History of symptomatic paroxysmal atrial fibrillation defined as:·
-Self-terminating AF lasting no more than seven days ·
-AF events demonstrating spontaneous conversion back to sinus rhythm·
-Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year6 months·
-AF symptoms defined as the manifestation of any of the following
-Palpitations
- Fatigue
-Exertional dyspnea
-Effort intolerance
2.Patient is refractory for at least 1 anti-arrhythmic drug
Exclusion criteria
1.Structural heart disease of clinical significance including:
-Previous cardiac surgery (excluding CABG)
-Symptoms of congestive heart failure including, but not limited to, NYHA Class III or IV CHF and/or documented ejection fraction < 40% measured by acceptable cardiac testing
-Left atrial diameter of > 50mm as measured in the parasternal long axis on transthoracic echocardiogram
-Stable/unstable angina or ongoing myocardial ischemia
-Myocardial infarction (MI) within three months of enrollment
-Aortic or mitral valve disease > Grade II
-Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
-Prior ASD or PFO closure with a device using a percutaneous approach
-Hypertrophic cardiomyopathy (LV wall thickness > 1.5 cm)
-Pulmonary hypertension (mean or systolic PA pressure >50mm Hg on Doppler echo)
2.Prior ablation for arrhythmias other than AF within the past three months
3.Cardioversion < 7 days before ablation procedure
4.Prior left sided AF ablation
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL31688.100.10 |