Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-11 @ 5:07 PM
Study NCT ID:
NCT02234102
Status:
UNKNOWN
Last Update Posted:
2015-08-21
First Post:
2014-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eagle AF (Atrial Fibrillation) - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-20', 'studyFirstSubmitDate': '2014-09-04', 'studyFirstSubmitQcDate': '2014-09-08', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds', 'timeFrame': 'Between day 90 and 365 after index procedure'}], 'secondaryOutcomes': [{'measure': 'Number of electrical cardioversions needed', 'timeFrame': '365 days after index procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Persistent Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* failure of at least one specific class I or III antiarrhythmic drug (AAD)\n* left atrial size \\< 50 mm\n* left ventricular ejection fraction \\> 45%\n* others\n* specific for PAF: diagnosed with self-terminating episodes for no longer than 7 days\n* specific for persistent AF: diagnosed with episodes of \\> 7 days and \\< 90 days\n\nExclusion Criteria:\n\n* AF secondary to a reversible cause of non-cardiac origin\n* uncontrollable hypertension\n* left atrial thrombus\n* others\n* specific for PAF: more than 1 electrical cardioversion in the year prior to enrollment\n* specific for persistent AF more than 4 electrical cardioversions in the year prior to enrollment'}, 'identificationModule': {'nctId': 'NCT02234102', 'briefTitle': 'Eagle AF (Atrial Fibrillation) - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Märkische Kliniken GmbH'}, 'officialTitle': 'Eagle AF - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'AF 34/2014 version 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paroxysmal Atrial Fibrillation (PAF)', 'description': 'Endoscopically guided laser ablation', 'interventionNames': ['Device: Endoscopically guided laser ablation HeartLight system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Persistent Atrial Fibrillation', 'description': 'Endoscopically guided laser ablation', 'interventionNames': ['Device: Endoscopically guided laser ablation HeartLight system']}], 'interventions': [{'name': 'Endoscopically guided laser ablation HeartLight system', 'type': 'DEVICE', 'otherNames': ['HeartLight system'], 'armGroupLabels': ['Paroxysmal Atrial Fibrillation (PAF)', 'Persistent Atrial Fibrillation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50733', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dinh Quang Nguyen, Dr.', 'role': 'CONTACT', 'email': 'DinhQuang.Nguyen@cellitinnen.de', 'phone': '+49 22177124059'}], 'facility': 'St.Vinzenz-Hospital GmbH', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '58515', 'city': 'Lüdenscheid', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus Zarse, PD Dr.', 'role': 'CONTACT', 'email': 'Markus.Zarse@klinikum-luedenscheid.de', 'phone': '+49 2351 4666299'}, {'name': 'Markus Zarse, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Märkische Kliniken GmbH, Klinik für Innere Medizin III', 'geoPoint': {'lat': 51.21977, 'lon': 7.6273}}, {'zip': '13407', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Niels Christian Ewertsen, Dr.', 'role': 'CONTACT', 'email': 'Niels-Christian.Ewertsen@vivantes.de', 'phone': '+49 30130225167'}], 'facility': 'Vivantes Netzwerk für Gesundheit GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Bernd Lemke, Prof. Dr.', 'role': 'CONTACT', 'email': 'Bernd.Lemke@klinikum-luedenscheid.de', 'phone': '+49 2351 4665551'}, {'name': 'Markus Zarse, PD Dr.', 'role': 'CONTACT', 'email': 'Markus.Zarse@klinikum-luedenscheid.de', 'phone': '+49 2351 4666299'}], 'overallOfficials': [{'name': 'Bernd Lemke, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Lüdenscheid Klinik f. Innere Medizin III'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. med. Bernd Lemke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Klinikdirektor der Klinik für Innere Medizin III', 'investigatorFullName': 'Prof. Dr. med. Bernd Lemke', 'investigatorAffiliation': 'Märkische Kliniken GmbH'}}}}