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

NCT ID: NCT02234102

Last Updated: 2015-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paroxysmal Atrial Fibrillation (PAF)

Endoscopically guided laser ablation

Group Type ACTIVE_COMPARATOR

Endoscopically guided laser ablation HeartLight system

Intervention Type DEVICE

Persistent Atrial Fibrillation

Endoscopically guided laser ablation

Group Type ACTIVE_COMPARATOR

Endoscopically guided laser ablation HeartLight system

Intervention Type DEVICE

Interventions

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Endoscopically guided laser ablation HeartLight system

Intervention Type DEVICE

Other Intervention Names

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HeartLight system

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. med. Bernd Lemke

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Bernd Lemke

Klinikdirektor der Klinik für Innere Medizin III

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bernd Lemke, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Lüdenscheid Klinik f. Innere Medizin III

Locations

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St.Vinzenz-Hospital GmbH

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Märkische Kliniken GmbH, Klinik für Innere Medizin III

Lüdenscheid, North Rhine-Westphalia, Germany

Site Status RECRUITING

Vivantes Netzwerk für Gesundheit GmbH

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Bernd Lemke, Prof. Dr.

Role: CONTACT

[email protected]
+49 2351 4665551

Markus Zarse, PD Dr.

Role: CONTACT

[email protected]
+49 2351 4666299

Facility Contacts

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Dinh Quang Nguyen, Dr.

Role: primary

[email protected]
+49 22177124059

Markus Zarse, PD Dr.

Role: primary

[email protected]
+49 2351 4666299

Niels Christian Ewertsen, Dr.

Role: primary

[email protected]
+49 30130225167

Other Identifiers

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AF 34/2014 version 02

Identifier Type: -

Identifier Source: org_study_id

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