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Completed

NCT Number: NCT01696136

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Utrecht, 3534CM, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Age between 18 and 70
  • Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study

Exclusion criteria

  • 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
  • Prior ablation for arrhythmias other than AF within the past three months
  • Prior left sided AF ablation
  • 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

Treatment and study plan

Cardiac ablation for Atrial Fibrillation

Device

Cardiac ablation for Atrial Fibrillation

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

L.V.A. Boersma

Other

Registry information

Official study title

Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for PAF a Randomized Multinational Multicenter Trial

Acronym: MYSTIC-PAF

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 28, 2012
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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