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Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartLight(TM) Laser Balloon | Active Comparator | Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation) |
|
| irrigated radiofrequency current ablation | Active Comparator | Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartLight(TM) Laser Balloon | Device | With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided |
|
| Measure | Description | Time Frame |
|---|---|---|
| Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds | between day 90 and 365 days after index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Schmidt, Dr. | Cardioangiologisches Centrum Bethanien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce Hospital | Prague | 15030 | Czechia | |||
| Herz- und Gefäß-Klinik GmbH Bad Neustadt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29217521 | Derived | Schmidt B, Neuzil P, Luik A, Osca Asensi J, Schrickel JW, Deneke T, Bordignon S, Petru J, Merkel M, Sediva L, Klostermann A, Perrotta L, Cano O, Chun KRJ. Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Study. Circ Arrhythm Electrophysiol. 2017 Dec;10(12):e005767. doi: 10.1161/CIRCEP.117.005767. |
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| irrigated radiofrequency current ablation | Device | The irrigated radiofrequency current ablation is used for pulmonary vein isolation |
|
| Bad Neustadt an der Saale |
| Bavaria |
| 97616 |
| Germany |
| Rheinische Friedrich-Wilhelms-Universität Bonn | Bonn | North Rhine-Westphalia | 53105 | Germany |
| Cardioangiologisches Centrum Bethanien | Frankfurt am Main | 60431 | Germany |
| Städtisches Klinikum Karlsruhe, Medizinische Klinik IV | Karlsruhe | 76133 | Germany |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| 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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