Eagle AF (Atrial Fibrillation) - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation

Prof. Dr. med. Bernd Lemke

Status: Unknown

Conditions: Persistent Atrial Fibrillation

Treatments: Device: Endoscopically guided laser ablation HeartLight system

Study type: Interventional

Funder types: Other

Identifiers

NCT02234102

AF 34/2014 version 02

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• failure of at least one specific class I or III antiarrhythmic drug (AAD)
• left atrial size < 50 mm
• left ventricular ejection fraction > 45%
• others
• specific for PAF: diagnosed with self-terminating episodes for no longer than 7 days
• specific for persistent AF: diagnosed with episodes of > 7 days and < 90 days

Exclusion criteria

• AF secondary to a reversible cause of non-cardiac origin
• uncontrollable hypertension
• left atrial thrombus
• others
• specific for PAF: more than 1 electrical cardioversion in the year prior to enrollment
• specific for persistent AF more than 4 electrical cardioversions in the year prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Paroxysmal Atrial Fibrillation (PAF)

Active Comparator group

Description:

Endoscopically guided laser ablation

Treatment:

Device: Endoscopically guided laser ablation HeartLight system

Persistent Atrial Fibrillation

Active Comparator group

Description:

Endoscopically guided laser ablation

Treatment:

Device: Endoscopically guided laser ablation HeartLight system