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The study aims to compare the results of pulmonary vein isolation (PVI) with a single technology approach in patients suffering from paroxysmal atrial fibrillation (PAF) with patients who have persistent AF of less than 3 months. Many studies have shown that electrical reconnection of the pulmonary veins following the index procedure can occur in up to 40% of targeted veins leading to a recurrence of PAF. Endoscopically guided laser ablation utilising the HeartLight system (CardioFocus Inc., USA) has been shown to be safe and effective and has also shown promising rates of durable isolation compared to point by point radio frequency techniques. However, the impact of employing this technique for patients with persistent AF has not yet been reported. The study hypothesis is that there will be no statistically significant difference between the results of PVI in the two groups of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxysmal Atrial Fibrillation (PAF) | Active Comparator | Endoscopically guided laser ablation |
|
| Persistent Atrial Fibrillation | Active Comparator | Endoscopically guided laser ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopically guided laser ablation HeartLight system | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds | Between day 90 and 365 after index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of electrical cardioversions needed | 365 days after index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bernd Lemke, Prof. Dr. | Contact | +49 2351 4665551 | Bernd.Lemke@klinikum-luedenscheid.de | |
| Markus Zarse, PD Dr. | Contact | +49 2351 4666299 | Markus.Zarse@klinikum-luedenscheid.de |
| Name | Affiliation | Role |
|---|---|---|
| Bernd Lemke, Prof. Dr. | Klinikum Lüdenscheid Klinik f. Innere Medizin III | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Vinzenz-Hospital GmbH | Recruiting | Cologne | North Rhine-Westphalia | 50733 | Germany |
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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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| Märkische Kliniken GmbH, Klinik für Innere Medizin III | Recruiting | Lüdenscheid | North Rhine-Westphalia | 58515 | Germany |
|
| Vivantes Netzwerk für Gesundheit GmbH | Recruiting | Berlin | State of Berlin | 13407 | Germany |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |