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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 is currently recruiting participants.
Verified September 2012 by R&D Cardiologie
Sponsor:
Information provided by (Responsible Party):
L.V.A. Boersma, R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT01696136
First received: September 26, 2012
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by R&D Cardiologie:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696136

Contacts
Contact: L.V.A. Boersma, MD PhD +31-30-6099111 l.boersma@antoniusziekenhuis.nl

Locations
Netherlands
St. Antonius Ziekenhuis Nieuwegein Recruiting
Nieuwegein, Utrecht, Netherlands, 3534CM
Contact: M.A.R. Bosschaert, MD     +31-30-6092278     m.bosschaert@antoniusziekenhuis.nl    
Principal Investigator: L.V.A. Boersma, MD PhD            
Sponsors and Collaborators
L.V.A. Boersma
  More Information

No publications provided

Responsible Party: L.V.A. Boersma, Cardiologist, R&D Cardiologie
ClinicalTrials.gov Identifier: NCT01696136     History of Changes
Other Study ID Numbers: RDC-2010.01
Study First Received: September 26, 2012
Last Updated: September 27, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by 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

ClinicalTrials.gov processed this record on May 21, 2013