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

NCT ID: NCT01696136

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-08-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AF-Ablation with Multi-electrode catheter

Regular AF-ablation with a multi-electrode ablation catheter

Group Type: ACTIVE_COMPARATOR

Cardiac ablation for Atrial Fibrillation

Intervention Type: DEVICE

Cardiac ablation for Atrial Fibrillation

AF-Ablation with single-tip electrode

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

Group Type: ACTIVE_COMPARATOR

Cardiac ablation for Atrial Fibrillation

Intervention Type: DEVICE

Cardiac ablation for Atrial Fibrillation

Interventions

Cardiac ablation for Atrial Fibrillation

Cardiac ablation for Atrial Fibrillation

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

L.V.A. Boersma

OTHER

Sponsor Role: lead

Responsible Party

L.V.A. Boersma

Cardiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Utrecht, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 27071830 (View on PubMed)

Other Identifiers

RDC-2010.01

Identifier Type: -

Identifier Source: org_study_id