Multi-electrode PulmonarY Vein isolation vs Single Tip wide area Catheter ablation for Paroxysmal Atrial Fibrillation

Multi-electrode PulmonarY Vein isolation vs Single Tip wide area Catheter ablation for Paroxysmal Atrial Fibrillation - MYSTIC-PAF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36751

Enrollment

Registered

2011-01-06

Start date

2011-01-25

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation heartrhythm disorder

Interventions

Catheterablation with either the multi-electrode PVAC catheter, or the single-tip catheter

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.History of symptomatic paroxysmal atrial fibrillation defined as:· -Self-terminating AF lasting no more than seven days · -AF events demonstrating 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 year6 months· -AF symptoms defined as the manifestation of any of the following -Palpitations - Fatigue -Exertional dyspnea -Effort intolerance 2.Patient is refractory for at least 1 anti-arrhythmic drug

Exclusion criteria

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 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.Cardioversion

Design outcomes

Primary

Measure	Time frame
The primary effectiveness endpoint for the study is -absence of symptomatic atrial fibrillation -and freedom from secondary atrial arrhythmias at 3, 6 and 12 months post-procedure by: · Repeated ECG · repeated 48-hour Holter in asymptomatic patients · event-recorder in symptomatic patients. The safety endpoint is the measurement of a composite list of procedure and device related serious adverse events followed for seven days. SAEs will include: · Stroke· Major bleeding requiring surgical intervention · Cardiac tamponade· PV stenosis· Myocardial infarction · Diaphragmatic paralysis · Atrio-esophageal fistula · Death	—

Measure

Time frame

The primary effectiveness endpoint for the study is -absence of symptomatic atrial fibrillation -and freedom from secondary atrial arrhythmias at 3, 6 and 12 months post-procedure by: · Repeated ECG · repeated 48-hour Holter in asymptomatic patients · event-recorder in symptomatic patients. The safety endpoint is the measurement of a composite list of procedure and device related serious adverse events followed for seven days. SAEs will include: · Stroke· Major bleeding requiring surgical intervention · Cardiac tamponade· PV stenosis· Myocardial infarction · Diaphragmatic paralysis · Atrio-esophageal fistula · Death

—

Secondary

Measure	Time frame
Secondaire effectiviteits eindpunten: - Improvement of symptoms after 3 and 12 month - Duration of RF burden - Skin-skin time for the ablation procedure - Fluoroscopy time	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)