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The GOLD FORCE trial investigates the differences between treatment with a Contact Force single-tip catheter against the PVAC GOLD 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 Contact Force single-tip electrode | Active Comparator | Regular AF-ablation with a regular Contact Force single-tip ablation catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVAC GOLD multielectrode catheter | Device | Cardiac ablation for Atrial Fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants free of Atrial Fibrillation 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 tachy-arrhythmias 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 |
|---|---|---|---|---|---|---|
| Praxisklinik Herz und Gefäße | Dresden | D-01099 | Germany | |||
| St. Antonius Ziekenhuis Nieuwegein |
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| Contact Force single-tip ablation catheter | Device |
|
| Nieuwegein |
| Utrecht |
| 3534CM |
| Netherlands |
| Isala Klinieken | Zwolle | 8011JW | Netherlands |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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