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

Not Applicable

• Conditions: Persistent Atrial Fibrillation
• Interventions: Device: Endoscopically guided laser ablation HeartLight system

• Registration Number: NCT02234102
• Lead Sponsor: Prof. Dr. med. Bernd Lemke

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-21
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paroxysmal Atrial Fibrillation (PAF)	Endoscopically guided laser ablation HeartLight system	Endoscopically guided laser ablation
Persistent Atrial Fibrillation	Endoscopically guided laser ablation HeartLight system	Endoscopically guided laser ablation

Primary Outcome Measures

Name	Time	Method
Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds	Between day 90 and 365 after index procedure

Secondary Outcome Measures

Name	Time	Method
Number of electrical cardioversions needed	365 days after index procedure

Trial Locations

Locations (3)

Märkische Kliniken GmbH, Klinik für Innere Medizin III; 🇩🇪 Lüdenscheid, NRW, Germany

St.Vinzenz-Hospital GmbH; 🇩🇪 Köln, NRW, Germany

Vivantes Netzwerk für Gesundheit GmbH; 🇩🇪 Berlin, Germany