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The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartLight® EGLA | Active Comparator | Participants will be treated with the endoscopically guided laser ablation catheter |
|
| Contact Force Sensing Irrigated RF ablation | Active Comparator | Participants will be treated with a contact force sensing irrigated radiofrequency ablation catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation catheter | Device | Ablation of paroxysmal atrial fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs | Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure | 12 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Acute procedure success | Confirmation of electrical isolation with a circular mapping catheter | 30 minutes post procedure |
| Procedure and fluoroscopy time | Time will be taken |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Metzner, PD Dr. med. | Universitäres Herz- und Gefäßzentrum UKE Hamburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartcentrum OLV Aalst | Aalst | 9300 | Belgium | |||
| Hartcentrum Hasselt Jessa Ziekenhuis |
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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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| During procedure |
| Incidence of peri-procedural complications | E.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombo-embolic events, pulmonary vein (PV) -stenosis, atrial-to-esophageal fistula, death | From procedure to 12 months post procedure |
| Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs | Recurrent ATA is defined as any documented episode of ATA lasting more than 30 seconds after a blanking period of 90 days post procedure | 12 months post procedure |
| Hasselt |
| 3500 |
| Belgium |
| Nemocnice Na Homolce | Prague | 15030 | Czechia |
| Universitätsklinik Erlangen | Erlangen | Bavaria | 91054 | Germany |
| Isar Herz Zentrum | München | Bavaria | 80331 | Germany |
| St. Vinzenz Hospital Köln | Cologne | North Rhine-Westphalia | 50733 | Germany |
| UKSH, Universitäres Herzzentrum | Lübeck | Schleswig-Holstein | 23562 | Germany |
| Vivantes Klinikum Am Urban | Berlin | 10967 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Universitäres Herz- und Gefäßzentrum UKE Hamburg | Hamburg | 20251 | Germany |
| Blackpool Victoria Hospital | Blackpool | FY3 8NR | United Kingdom |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |