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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AF-Ablation with Multi-electrode catheter | Active Comparator | Regular AF-ablation with a multi-electrode ablation catheter |
|
| AF-Ablation with single-tip electrode | Active Comparator | Regular AF-ablation with a regular single-tip ablation catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac ablation for Atrial Fibrillation | Device | Cardiac ablation for Atrial Fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | Utrecht | 3534CM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27071830 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |