Clinical trial NCT01696136: Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation (PAF)
Official title: Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for PAF a Randomized Multinational Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Ablation
Multi-electrode catheter
Single-tip catheter
Holter
Lead sponsor: R&D Cardiologie
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The MYSTIC_PAF trial investigates the differences between treatment with a single-tip catheter against a multielectrode catheter in cardiac ablation procedures in patients with paroxysmal atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

1. History of symptomatic paroxysmal atrial fibrillation defined as:

   * Self-terminating AF with episodes lasting no more than seven consecutive days before 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 year
   * AF symptoms defined as the manifestation of any of the following:

     * Palpitations
     * Fatigue
     * Exertional dyspnea
     * Effort intolerance
2. Age between 18 and 70
3. Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study

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. Prior left sided AF ablation
4. Enrollment in any other ongoing arrhythmia study protocol Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study

Primary outcomes:
measure: Freedom of AF
timeFrame: Month 3 after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
state: Utrecht
Study officials:
References:
citation: Boersma LV, van der Voort P, Debruyne P, Dekker L, Simmers T, Rossenbacker T, Balt J, Wijffels M, Degreef Y. Multielectrode Pulmonary Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation: A Multinational Multicenter Randomized Clinical Trial. Circ Arrhythm Electrophysiol. 2016 Apr;9(4):e003151. doi: 10.1161/CIRCEP.115.003151.