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

Eagle AF - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02234102

Enrollment

160

Registered

2014-09-09

Start date

2014-08-31

Completion date

2017-06-30

Last updated

2015-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Atrial Fibrillation

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.

Interventions

DEVICEEndoscopically guided laser ablation HeartLight system

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Primary ContactBernd Lemke, Prof. Dr.

Bernd.Lemke@klinikum-luedenscheid.de+49 2351 4665551

Backup ContactMarkus Zarse, PD Dr.

Markus.Zarse@klinikum-luedenscheid.de+49 2351 4666299

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026