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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:
ClinicalTrials.gov Identifier:
NCT01696136
First Posted: September 28, 2012
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
L.V.A. Boersma, R&D Cardiologie
  Purpose
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.

Condition Intervention
Atrial Fibrillation Device: Cardiac ablation for Atrial Fibrillation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for PAF a Randomized Multinational Multicenter Trial

Resource links provided by NLM:


Further study details as provided by L.V.A. Boersma, R&D Cardiologie:

Primary Outcome Measures:
  • Freedom of AF [ Time Frame: Month 3 after intervention ]
    Is the patient free of Atrial Fibrillation, at month 3 after the ablation intervention, and not taking anti-arrhythmic drugs


Estimated Enrollment: 120
Study Start Date: January 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AF-Ablation with Multi-electrode catheter
Regular AF-ablation with a multi-electrode ablation catheter
Device: Cardiac ablation for Atrial Fibrillation
Cardiac ablation for Atrial Fibrillation
Active Comparator: AF-Ablation with single-tip electrode
Regular AF-ablation with a regular single-tip ablation catheter
Device: Cardiac ablation for Atrial Fibrillation
Cardiac ablation for Atrial Fibrillation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696136


Locations
Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, Utrecht, Netherlands, 3534CM
Sponsors and Collaborators
L.V.A. Boersma
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: L.V.A. Boersma, Cardiologist, R&D Cardiologie
ClinicalTrials.gov Identifier: NCT01696136     History of Changes
Other Study ID Numbers: RDC-2010.01
First Submitted: September 26, 2012
First Posted: September 28, 2012
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by L.V.A. Boersma, R&D Cardiologie:
Ablation
Multi-electrode catheter
Single-tip catheter
Holter

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes