Eagle AF (Atrial Fibrillation) - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation
NCT02234102 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2015-08-21
Summary
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.
Conditions
- Persistent Atrial Fibrillation
Interventions
- DEVICE
-
Endoscopically guided laser ablation HeartLight system
Sponsors & Collaborators
-
Prof. Dr. med. Bernd Lemke
lead OTHER
Principal Investigators
-
Bernd Lemke, Prof. Dr. · Klinikum Lüdenscheid Klinik f. Innere Medizin III
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2016-12-31
- Completion
- 2017-06-30
Countries
- Germany
Study Locations
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