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

Eagle AF - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation

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.

Study Overview

• Status: Unknown
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Endoscopically guided laser ablation HeartLight system

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bernd Lemke, Prof. Dr.; Phone Number: +49 2351 4665551; Email: Bernd.Lemke@klinikum-luedenscheid.de
• Study Contact Backup: Name: Markus Zarse, PD Dr.; Phone Number: +49 2351 4666299; Email: Markus.Zarse@klinikum-luedenscheid.de

Study Locations

• Germany
  • Berlin, Germany, 13407
    • Recruiting
    • Vivantes Netzwerk für Gesundheit GmbH
    • Contact: Niels Christian Ewertsen, Dr.; Phone Number: +49 30130225167; Email: Niels-Christian.Ewertsen@vivantes.de
  • NRW
    • Köln, NRW, Germany, 50733
      • Recruiting
      • St.Vinzenz-Hospital GmbH
      • Contact: Dinh Quang Nguyen, Dr.; Phone Number: +49 22177124059; Email: DinhQuang.Nguyen@cellitinnen.de
    • Lüdenscheid, NRW, Germany, 58515
      • Recruiting
      • Märkische Kliniken GmbH, Klinik für Innere Medizin III
      • Contact: Markus Zarse, PD Dr.; Phone Number: +49 2351 4666299; Email: Markus.Zarse@klinikum-luedenscheid.de
      • Principal Investigator: Markus Zarse, PD Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paroxysmal Atrial Fibrillation (PAF); Endoscopically guided laser ablation	Device: Endoscopically guided laser ablation HeartLight system; Other Names: HeartLight system
Active Comparator: Persistent Atrial Fibrillation; Endoscopically guided laser ablation	Device: Endoscopically guided laser ablation HeartLight system; Other Names: HeartLight system

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of electrical cardioversions needed	365 days after index procedure

Collaborators and Investigators

• Sponsor: Prof. Dr. med. Bernd Lemke
• Investigators: Principal Investigator: Bernd Lemke, Prof. Dr., Klinikum Lüdenscheid Klinik f. Innere Medizin III

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Estimate): August 21, 2015
• Last Update Submitted That Met QC Criteria: August 20, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AF 34/2014 version 02