NCT01696136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

3.6 years

First QC Date

September 26, 2012

Last Update Submit

May 27, 2015

Conditions

Atrial Fibrillation

Keywords

AblationMulti-electrode catheterSingle-tip catheterHolter

Outcome Measures

Primary Outcomes (1)

  • Freedom of AF

    Is the patient free of Atrial Fibrillation, at month 3 after the ablation intervention, and not taking anti-arrhythmic drugs

    Month 3 after intervention

Study Arms (2)

AF-Ablation with Multi-electrode catheter

ACTIVE COMPARATOR

Regular AF-ablation with a multi-electrode ablation catheter

Device: Cardiac ablation for Atrial Fibrillation

AF-Ablation with single-tip electrode

ACTIVE COMPARATOR

Regular AF-ablation with a regular single-tip ablation catheter

Device: Cardiac ablation for Atrial Fibrillation

Interventions

Cardiac ablation for Atrial FibrillationDEVICE

Cardiac ablation for Atrial Fibrillation

AF-Ablation with Multi-electrode catheterAF-Ablation with single-tip electrode

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Utrecht, 3534CM, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 27071830DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

September 26, 2012

First Posted

September 28, 2012

Study Start

January 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

NL(1)