Eagle AF (Atrial Fibrillation) - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation
Primary Purpose
Persistent Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Endoscopically guided laser ablation HeartLight system
Sponsored by

About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- St.Vinzenz-Hospital GmbHRecruiting
- Märkische Kliniken GmbH, Klinik für Innere Medizin IIIRecruiting
- Vivantes Netzwerk für Gesundheit GmbHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Paroxysmal Atrial Fibrillation (PAF)
Persistent Atrial Fibrillation
Arm Description
Endoscopically guided laser ablation
Endoscopically guided laser ablation
Outcomes
Primary Outcome Measures
Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds
Secondary Outcome Measures
Number of electrical cardioversions needed
Full Information
NCT ID
NCT02234102
First Posted
September 4, 2014
Last Updated
August 20, 2015
Sponsor
Prof. Dr. med. Bernd Lemke
1. Study Identification
Unique Protocol Identification Number
NCT02234102
Brief Title
Eagle AF (Atrial Fibrillation) - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation
Official Title
Eagle AF - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. med. Bernd Lemke
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paroxysmal Atrial Fibrillation (PAF)
Arm Type
Active Comparator
Arm Description
Endoscopically guided laser ablation
Arm Title
Persistent Atrial Fibrillation
Arm Type
Active Comparator
Arm Description
Endoscopically guided laser ablation
Intervention Type
Device
Intervention Name(s)
Endoscopically guided laser ablation HeartLight system
Other Intervention Name(s)
HeartLight system
Primary Outcome Measure Information:
Title
Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds
Time Frame
Between day 90 and 365 after index procedure
Secondary Outcome Measure Information:
Title
Number of electrical cardioversions needed
Time Frame
365 days after index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernd Lemke, Prof. Dr.
Phone
+49 2351 4665551
Email
Bernd.Lemke@klinikum-luedenscheid.de
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Zarse, PD Dr.
Phone
+49 2351 4666299
Email
Markus.Zarse@klinikum-luedenscheid.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Lemke, Prof. Dr.
Organizational Affiliation
Klinikum Lüdenscheid Klinik f. Innere Medizin III
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Vinzenz-Hospital GmbH
City
Köln
State/Province
NRW
ZIP/Postal Code
50733
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinh Quang Nguyen, Dr.
Phone
+49 22177124059
Email
DinhQuang.Nguyen@cellitinnen.de
Facility Name
Märkische Kliniken GmbH, Klinik für Innere Medizin III
City
Lüdenscheid
State/Province
NRW
ZIP/Postal Code
58515
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Zarse, PD Dr.
Phone
+49 2351 4666299
Email
Markus.Zarse@klinikum-luedenscheid.de
First Name & Middle Initial & Last Name & Degree
Markus Zarse, PD Dr.
Facility Name
Vivantes Netzwerk für Gesundheit GmbH
City
Berlin
ZIP/Postal Code
13407
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels Christian Ewertsen, Dr.
Phone
+49 30130225167
Email
Niels-Christian.Ewertsen@vivantes.de
12. IPD Sharing Statement
Learn more about this trial
Eagle AF (Atrial Fibrillation) - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation
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