Atrial FibrillationMYSTIC-PAFNCT01696136
Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation (PAF)
A study testing Cardiac ablation for Atrial Fibrillation in people with Atrial Fibrillation, run by L.V.A. Boersma at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cardiac ablation for Atrial Fibrillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, Utrecht, 3534CM
About this study
Official title: Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for PAF a Randomized Multinational Multicenter Trial
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
- Being tested
- Cardiac ablation for Atrial Fibrillation
- Keywords
- Ablation, Multi-electrode catheter, Single-tip catheter, Holter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac ablation for Atrial FibrillationDevice
Cardiac ablation for Atrial Fibrillation
| Study group | Role | What they receive |
|---|---|---|
| AF-Ablation with Multi-electrode catheter | Active comparator | Regular AF-ablation with a multi-electrode ablation catheter Receives: Device: Cardiac ablation for Atrial Fibrillation |
| AF-Ablation with single-tip electrode | Active comparator | Regular AF-ablation with a regular single-tip ablation catheter Receives: Device: Cardiac ablation for Atrial Fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of AF
Is the patient free of Atrial Fibrillation, at month 3 after the ablation intervention, and not taking anti-arrhythmic drugs
Measured: Month 3 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L.V.A. Boersma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, L.V.A. Boersma, R&D Cardiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696136
- Sponsor's protocol ID
- RDC-2010.01
- Acronym
- MYSTIC-PAF
- Status last verified
- May 2015
- First submitted
- 26 Sep 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27071830
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for PAF a Randomized Multinational Multicenter Trial
- ClinicalTrials.gov ID
- NCT01696136
- Acronym / sponsor ID
- MYSTIC-PAF / RDC-2010.01
- Conditions
- Atrial Fibrillation
- Keywords
- Ablation, Multi-electrode catheter, Single-tip catheter, Holter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- L.V.A. BoersmaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF-Ablation with Multi-electrode catheter | Active comparator | Device: Cardiac ablation for Atrial FibrillationRegular AF-ablation with a multi-electrode ablation catheter |
| AF-Ablation with single-tip electrode | Active comparator | Device: Cardiac ablation for Atrial FibrillationRegular AF-ablation with a regular single-tip ablation catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- History of symptomatic paroxysmal atrial fibrillation defined as:
- Age between 18 and 70
- Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
Key exclusion criteria (14 listed)
- Structural heart disease of clinical significance including:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac ablation for Atrial FibrillationCardiac ablation for Atrial Fibrillation | Device | AF-Ablation with Multi-electrode catheter, AF-Ablation with single-tip electrode |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 27071830Boersma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac ablation for Atrial Fibrillation in people with Atrial Fibrillation, run by L.V.A. Boersma at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom of AF (time frame: Month 3 after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01696136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.