Multi-electrode PulmonarY Vein isolation vs Single Tip wide area Catheter ablation for Paroxysmal Atrial Fibrillatio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary effectiveness endpoint for the study is<br /><br>-absence of symptomatic atrial fibrillation<br /><br>-and freedom from secondary atrial arrhythmias at 3, 6 and 12 months<br /><br>post-procedure by:<br /><br>· Repeated ECG<br /><br>· repeated 48-hour Holter in asymptomatic patients<br /><br>· event-recorder in symptomatic patients.<br /><br><br /><br>The safety endpoint is the measurement of a composite list of<br /><br>procedure and device related serious adverse events followed for seven days.<br /><br>SAEs will include:<br /><br>· Stroke· Major bleeding requiring surgical intervention<br /><br>· Cardiac tamponade· PV stenosis· Myocardial infarction<br /><br>· Diaphragmatic paralysis<br /><br>· Atrio-esophageal fistula<br /><br>· Death</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondaire effectiviteits eindpunten:<br /><br>- Improvement of symptoms after 3 and 12 month<br /><br>- Duration of RF burden<br /><br>- Skin-skin time for the ablation procedure<br /><br>- Fluoroscopy time</p><br>