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

Persistent Atrial Fibrillation Clinical Trial

Official title:

Eagle AF - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02234102
• Other study ID #: AF 34/2014 version 02
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2014
• Last updated: August 20, 2015
• Start date: August 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2015
• Source: Märkische Kliniken GmbH
• Contact: Bernd Lemke, Prof. Dr.
• Phone: +49 2351 4665551
• Email: Bernd.Lemke[@]klinikum-luedenscheid.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Endoscopically guided laser ablation HeartLight system

Locations

Country	Name	City	State
Germany	Vivantes Netzwerk für Gesundheit GmbH	Berlin
Germany	St.Vinzenz-Hospital GmbH	Köln	NRW
Germany	Märkische Kliniken GmbH, Klinik für Innere Medizin III	Lüdenscheid	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. med. Bernd Lemke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds		Between day 90 and 365 after index procedure	No
Secondary	Number of electrical cardioversions needed		365 days after index procedure	No