Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation (PAF) (MYSTIC-PAF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
L.V.A. Boersma, R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT01696136
First received: September 26, 2012
Last updated: May 27, 2015
Last verified: May 2015

September 26, 2012
May 27, 2015
January 2011
August 2014   (final data collection date for primary outcome measure)
Freedom of AF [ Time Frame: Month 3 after intervention ] [ Designated as safety issue: No ]
Is the patient free of Atrial Fibrillation, at month 3 after the ablation intervention, and not taking anti-arrhythmic drugs
Same as current
Complete list of historical versions of study NCT01696136 on ClinicalTrials.gov Archive Site
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Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation (PAF)
Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for PAF a Randomized Multinational Multicenter Trial
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.
Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Device: Cardiac ablation for Atrial Fibrillation
Cardiac ablation for Atrial Fibrillation
  • Active Comparator: AF-Ablation with Multi-electrode catheter
    Regular AF-ablation with a multi-electrode ablation catheter
    Intervention: Device: Cardiac ablation for Atrial Fibrillation
  • Active Comparator: AF-Ablation with single-tip electrode
    Regular AF-ablation with a regular single-tip ablation catheter
    Intervention: Device: Cardiac ablation for Atrial Fibrillation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01696136
RDC-2010.01
No
Not Provided
Not Provided
L.V.A. Boersma, R&D Cardiologie
L.V.A. Boersma
Not Provided
Not Provided
R&D Cardiologie
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP